Sunday, January 27, 2013

Suture production

All Sewn Up: Postcesarean Skin Staples vs. Subcuticular Sutures Subcuticular closure was associated with lower risk for wound complications.

As the cesarean delivery rate climbs, we are increasingly obliged to determine best practices for the procedure. In particular, averting wound-related complications would lower postcesarean morbidity considerably. Whether skin staples are better than subcuticular suture closure is not known; thus, investigators in Alabama conducted a randomized, controlled trial of the two methods in 393 women undergoing scheduled or unscheduled cesarean deliveries.

Regardless of maternal body-mass index (BMI; mean, 36 kg/m 2 ), women in the staple group were more likely than those in the suture group to suffer wound disruption or infection by 4 to 6 weeks postpartum (14.5% vs. 5.9%; relative risk, 2.5). Most complications consisted of wound disruption (RR, 3.8), and much of the difference in outcomes occurred before hospital discharge. Use of subcuticular closure added 10 minutes to median operating time (from 48 to 58 minutes; P <0.001). Patient-centered measures such as pain, cosmesis, and satisfaction did not differ between groups.

Comment: As we scrutinize the quality of care that we provide for its impact on patient safety and satisfaction, trials such as this are especially valuable. Although the study population was enriched for factors associated with wound complications (e.g., high body-mass index), the benefits of subcuticular closure persisted even in low-risk women (BMI <30, primary cesarean, no preceding chorioamnionitis). As the authors note, the costs associated with longer operative times are probably rivaled by costs associated with wound morbidity, the surgical stapler itself, and the time required to remove staples. This trial adds to the mounting evidence that subcuticular suturing is the best method for postcesarean skin closure.

Sunday, January 6, 2013

DISCUSSION ON RADIOISOTOPE & RADIOPHARMACEUTICAL: IT’S USES

RADIOPHARMACEUTICALS
Radiopharmaceuticals are drugs containing a radionuclide and are used routinely in nuclear medicine for the diagnosis and therapy of various diseases. Depending upon their medical applications radiopharmaceuticals are divided into two classes’ viz. diagnostic radiopharmaceuticals and therapeutic radiopharmaceuticals. They are briefly discussed below.
Diagnostics Radiopharmaceuticals
Diagnostic radiopharmaceuticals are molecules which are tagged with a gamma ray emitting radioisotope. Such agents when administered into the body localize in certain organs or tissue, for which they are designed for, and the radiation emitted by the associated radionuclide could be detected from outside with the help of suitable instrument like gamma camera. The analysis of the resultant images obtained from the gamma camera could reveal useful information regarding the disease condition of the patient.
Therapeutic Radiopharmaceuticals
Therapeutic Radiopharmaceuticals are very similar much to the diagnostic radiopharmaceuticals but the only difference being the use of a therapeutic radionuclide instead of a diagnostic radionuclide. In this case the primary aim is not to get diagnostic information but to deliver therapeutic doses of ionizing radiations to specific diseased sites. Further discussion on therapeutic radiopharmaceuticals is beyond the scope of present work. The various isotope used as therapeutic, diagnostic or research work are listed below in table-1 [6]
Isotopes used in radiopharmaceuticals with application
Table-1
ISOTOPE
t1/2
APPLICATION
198Au
2.7 d
Therapeutic
Diagnostic
14C
5700 Y
Research
45Ca
165 d
Diagnostic
47Ca
4.5 d
Diagnostic
57Co
270 d
Diagnostic
58Co
71 d
Diagnostic
60Co
5.27 y
Therapeutic
Diagnostic
51Cr
27.8 d
Diagnostic
121Cs
9.7 d
Diagnostic
137Cs
30 y
Research
18F
1.7 H
Diagnostic
3H
12.3 y
Diagnostic
Research
59Fe
45 d
Diagnostic
197Hg
2.7 d
Diagnostic
203Hg
46.9 d
Diagnostic
125I
60 d
Diagnostic
Therapeutic
131I
8.08 d
Diagnostic
Therapeutic
Research
113In
1.66 h
Diagnostic
192Ir
74.4 d
Therapeutic
42K
12.4 h
Research
99Mo
2.8 d
Source of 99mTc
22Na
2.6 y
Diagnostic
24Na
15 h
Diagnostic
32P
14.3 d
Diagnostic
Therapeutic
Research
226Ra
1620 y
Therapeutic
86Rb
18.8 d
Diagnostic
222Rn
3.8 d
Therapeutic
35S
88 d
Research
75Se
120 d
Diagnostic
85Sr
64 d
Diagnostic
90Sr
28 y
Therapeutic
182Ta
115 d
Therapeutic
99mTc
6.0 h
Diagnostic
90Y
2.6 d
Diagnostic
Therapeutic
169Yb
32 d
Diagnostic
65Zn
245 d
Research

The use of radioisotope in medicine is different upon the type of radiation emitted by it. Usually beta and gamma radiation are utilized for medical purpose because of the case with which they can be detected and measure.
Uses of radioactivity/radiation
There are many practical applications to the use of radioactivity/radiation. Radioactive sources are used to study living organisms, to diagnose and treat diseases, to sterilize medical instruments and food, to produce energy for heat and electric power, and to monitor various steps in all types of industrial processes.
Tracers
Tracersare a common application of radioisotopes. A tracer is a radioactive element whose pathway through which a chemical reaction can be followed. Tracers are commonly used in the medical field and in the study of plants and animals. Radioactive Iodine-131 can be used to study the function of the thyroid gland assisting in detecting disease.
Nuclear reactors
Nuclear reactorsare devices that control fission reactions producing new substances from the fission product and energy. Recall our discussion earlier about the fission process in the making of a radioisotope. Nuclear power stations use uranium in fission reactions as a fuel to produce energy. Steam is generated by the heat released during the fission process. It is this steam that turns a turbine to produce electric energy.
Other uses of radioactivity
Sterilization of medical instruments and food is another common application of radiation. By subjecting the instruments and food to concentrated beams of radiation, we can kill microorganisms that cause contamination and disease. Because this is done with high energy radiation sources using electromagnetic energy, there is no fear of residual radiation. Also, the instruments and food may be handled without fear of radiation poisoning.
Radiation sources are extremely important to the manufacturing industries throughout the world. They are commonly employed by nondestructive testing personnel to monitor materials and processes in the making of the products we see and use every day. Trained technicians use radiography to image materials and products much like a dentist uses radiation to x-ray your teeth for cavities. There are many industrial applications that rely on radioactivity to assist in determining if the material or product is internally sound and fit for its application. Radioactive isotopes have many useful applications. In medicine, for example, cobalt-60 is extensively employed as a radiation source to arrest the development of cancer. Other radioactive isotopes are utilized as tracers for diagnostic purposes, as well as in research on metabolic processes. When a radioactive isotope is added in small amounts to comparatively large quantities of the stable element, it behaves exactly the same as the ordinary isotope chemically; it can, however, be traced with a Geiger counter or other detection device. Iodine-131 has proved effective in locating brain tumours, measuring cardiac output, and determining liver and thyroid activity. Another medically important radioactive isotope is carbon-14, which is useful in studying abnormalities of metabolism that underlie diabetes, gout, anemia, and acromegaly. In industry, radioactive isotopes of various kinds are used for measuring the thickness of metal or plastic sheets; their precise thickness is indicated by the strength of the radiations that penetrate the material being inspected. They also may be employed in place of large X-ray machines to examine manufactured metal parts for structural defects. Other significant applications include the use of radioactive isotopes as compact sources of electrical power—e.g., plutonium-238 in cardiac pacemakers and spacecraft. In such cases, the heat produced in the decay of the radioactive isotope is converted into electricity by means of thermoelectric junction circuits or related devices
The present invention relates to a filamentous fungus useful for the production of heterologous polypeptides, having been... modified by recombinant DNA technology in a manner by which the expression of alkaline proteases have been completely or partially inactivated. The invention also encompasses processes for the production of proteins of interest in..

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DISCUSSION ON RADIOISOTOPE & RADIOPHARMACEUTICAL: IT’S USES

INTRODUCTION
Radioactive nuclides, or radionuclides, are species of unstable atomic nuclei without the restriction of being forms of the same element. Radioactive nuclides consist of all the sets of radioactive isotopes. Radiochemistry a subdivision of chemistry which deals with the study of radioactive substances. it includes the nuclear transformation involved, transmutation of one element into another,and the nature and properties of the radiation emitted. it also deals with the use of this radiation in chemical tracer analysis, for geological & archeological (chemical dating), and for initiation of cross-lining(polymerazation)  [1] Spontaneous nuclear transformation of nuclide into another nuclide, accompanied by emission of nuclear radiation ,either corpuscular or electromagnetic. it may be natural, as with radium, artificial (caused bybombardment of a stable nucleus with neutrons or deuterons), or induced, as in radioactive carbon.the emanations are in the form of alpha, beta, gamma rays. the natural radioactive elements are uranium, radium, radon and thorium(the principal members of the uranium decay series), the ultimate end products being stable isotope of elements,e.g.,sodium,iodine etc., can be made radioactive by bombardment with neutrons, deuterons.or other heavy particles. Radionuclides, mainly 3H & 14C, are widely used as tracers in analysis, and in distribution and metabolism studies of drugs in animals.such isotope with long half-lives are not suitable for use in human medicine,but a number of radioisotopes with comparatively short half-lives, measured in hours or days,are now widely used in radiopharmaceutical preparations as diagnostic agents and in the treatment of neoplastic disease. these include 32P,51Cr,57Co,59Fe,75Se,125I.131I & 99mTc.  [2] Isotopes are generally distinguished by three analytical means. The first of them makes use of radioactive isotopes, such as tritium (3H), 14C, 32P etc. This is a highly sensitive technique, but special facilities are required to handle radioactive material. Mass spectroscopy can also be used to detect isotopes. This is also a highly sensitive technique. When the fragmentation pattern of a compound is known, mass spectral data provide a wealth of information. The third, and at present the most frequently used technique is nuclear magnetic resonance. This technique requires an NMR active nucleus such as 2H, 13C, 17O etc. and is relatively less sensitive. But the ease of operation more than compensates for its limitations.[3]
According to the different condition for storage ,handling,disposal and the manner in which the radionuclide are used they are categorized into two groups (1)sealed (2)unsealed. In radio therapy sealed radio isotope are used that are encapsulated to prevent the loss of the radioisotopes. On the other hand most radiopharmaceuticals are used in unsealed state. i.e. the radio isotope is present in the liquid , particular or gaseous state. These offers some hazards which include contamination by skin contact and accidental inhalation or ingestion.[4]

Types of radioactive isotopes by origin
1) Long-lived radioactive nuclides
Some radioactive nuclides that have very long half lives were created during the formation of the solar system (~4.6 billion years ago) and are still present in the earth. These include 40K (t½ = 1.28 billion years), 87Rb (t½ = 48.8 billion years), 238U (t½ = 447 billion years), and 186Os (t½ = 2 x 106 billion years, or 2 million billion years).
2) Cosmogenic
Cosmogenic isotopes are a result of cosmic ray activity in the atmosphere. Cosmic rays are atomic particles that are ejected from stars at a rate of speed sufficient to shatter other atoms when they collide. This process of transformation is called spallation. Some of the resulting fragments produced are unstable atoms having a different atomic structure (and atomic number), and so are isotopes of another element. The resulting atoms are considered to have cosmogenic radioactivity. Cosmogenic isotopes are also produced at the surface of the earth by direct cosmic ray irradiation of atoms in solid geologic materials.
Examples of cosmogenic nuclides include 14C, 36Cl, 3H, 32Si, and 10Be. Cosmogenic nuclides, since they are produced in the atmosphere or on the surface of the earth and have relatively short half-lives (10 to 30,000 years), are often used for age dating of waters.
3) Anthropogenic
Anthropogenic isotopes result from human activities, such as the processing of nuclear fuels, reactor accidents, and nuclear weapons testing. Such testing in the 1950s and 1960s greatly increased the amounts of tritium (3H) and 14C in the atmosphere; tracking these isotopes in the deep ocean, for instance, allows oceanographers to study ocean flow, currents, and rates of sedimentation. Likewise, in hydrology it allows for the tracking of recent groundwater recharge and flow rates in the vadose zone. Examples of hydrologically useful anthropogenic isotopes include many of the cosmogenic isotopes mentioned above: 3H, 14C, 36Cl, and 85Kr.
4) Radiogenic
Radiogenic isotopes are typically stable daughter isotopes produced from radioactive decay. In the geosciences, radiogenic isotopes help to determine the nature and timing of geological events and processes. Isotopic systems useful in this research are primarily K-Ar, Rb-Sr, Re-Os, Sm-Nd, U-Th-Pb, and the noble gases (4H, 3H-3He, 40Ar).
Because of their stable evolution in groundwater, such naturally occurring isotopes are useful hydrologic tracers, allowing evaluation of large geographic areas to determine flowpaths and flow rates. Consequently, they are helpful in building models that predict fracturing, aquifer thickness, and other subterranean features.
Production of radioisotope
Production of radioisotopes includes three principle categories, which are (1) neutron activation (bombardment), (2) fission product separation, and (3) charged particle bombardment. Nuclear bombardment constitutes the major method for obtaining industrially important radioisotope materials. Radioisotopes may exist in any form of matter, with solid materials comprising the largest group.
Emission of radioisotope
Three main type of radiation from radioactive substance are alpha(α),beta(β) and gamma(γ) rays.most source emit more than one type of emission, The penetrating power of each radiation varies considerably according to it’s nature and it’s energy. Alpha particle are completely absorbed in a thickness of a few micrometers to some tens of micrometer of solid or liquid. Beta particle are completely absorbed in a thickness of several millimeter to several centimeter. Gamma rays are not completely absorbed but only attenuated. The denser the absorbent , the shorter the range of alpha, beta particle and greater the attenuation of gamma rays.[5]
Cause of desirable effect of shorter half-lives radionuclide
In general, radionuclides (RN) with shorter half-lives are desirable for use in diagnostic nuclear medicine (NM) because they usually produce less total dose to the patient, thus yielding reduced biological impact compared to longer-lived radionuclides. Radionuclides that are selected for diagnostic NM procedures preferably emit photonic radiation (usually gamma rays) that have an energy in the approximate range from 100 to 150 keV. This energy is desirable since it is high enough to ensure reasonable penetration of the human body so that photons are able to reach the imaging device, usually a gamma camera; additionally this energy is detected with high efficiency by the detectors in the cameras and is low enough so that camera collimators work effectively to record primarily photons moving in a direction more-or-less perpendicular to the face of the detector. This is necessary in order to obtain acceptably sharp images without appreciable blurring. A final desirable property is that the radionuclide emits minimal amounts of particulate radiation such as beta particles and alpha particles so as not to produce excess patient dose while doing nothing to improve image quality. There are both long- and short-lived radionuclides that could fulfill these recommendations.
ABSTRACT:
Nanoparticle drug-delivery systems are the popular ones as are able to increase the selectivity and stability of therapeutic agents. However reticuloendothelial system (RES) uptake, drug leakage, immunogenicity, hemolytic toxicity, cytotoxicity, hydrophobicity restrict the use of these nanostructures. These shortcomings are overcome by surface engineering the dendrimer such as Polyester dendrimer, Citric acid dendrimer, Arginine dendrimer, Glycodendrimers, PEGylated dendrimers, etc.The field of Dendrimers has recently emerged as the most commercially viable technology of this century because of its wide-ranging potential applications in many fields such as: healthcare, electronics, photonics, biotechnology, engineering products, pharmaceuticals, drug delivery, catalysis, electronic devices, environmental issues and nanotechnologies. Dendrimer as a drug delivery agent is a promising, safe and selective drug delivery option.

ABSTRACT
Radioactive isotope, also called radioisotope,  any of several species of the same chemical element with different masses whose nuclei are unstable and dissipate excess energy by spontaneously emitting radiation in the form of alpha, beta, and gamma rays. Radioisotopes are elements that are atomically unstable and radioactive. Radioisotopes stabilize by releasing energy and matter. Natural radioisotopes, which have relatively low radioactive energy, have been largely replaced by artificially produced radioisotopes. Artificially produced radioisotopes are widely utilized as sources of radiation for radiography, gauging, and as tracers for a multitude of measurements that are not easily made by other methods. Radiopharmaceuticals are drugs containing a radionuclide and are used routinely in nuclear medicine for the diagnosis and therapy of various diseases. Presented article is concerned with brief discussion about the radioisotope & Radiopharmaceuticals.

ABSTRACT
Recent studies reported approval of lipid vesicles as drug carriers for chemotherapeutic agents and bio-actives which have been revealed in a number of lipid vesicles based formulations, which are commercially available or are currently undergoing clinical trials. This review is mainly focused on effectiveness and permeation enhancing controversy of lipid vesicles as dermal and transdermal drug delivery with special emphasis on recent advances in this field, including the development of deformable vesicles, ethosomes and invasomes. Only specially designed lipid vesicles have been shown to be capable of achieving enhanced delivery. The incorporation of additives, such as anionic surfactants and ethanol, fluidize the phospholipid bilayers, thus can penetrate the intercellular pathways of the skin.

ISOLATION, EXTRACTION, PURIFICATION AND CHARACTERIZATION OF ALKALINE PROTEASE FROM NEUROSPORA CRASSA AND ENZYME ASSAY



The present invention relates to a filamentous fungus useful for the production of heterologous polypeptides, having been... modified by recombinant DNA technology in a manner by which the expression of alkaline proteases have been completely or partially inactivated. The invention also encompasses processes for the production of proteins of interest in..

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INSTRUMENTATION OF ESR SPECTROSCOPY

It is a branch of absorption spectroscopy in which radiation having frequency in microwave region is absorbed by paramagnetic substance to induce transition between magnetic energy level of electron wit...h unpaired spin. Magnetic energy splitting is done by applying a static magnetic field...

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AN OVERVIEW OF LIQUID CHROMATOGRAPHY COUPLED WITH TANDEM MASS SPECTROSCOPY (LC-MS/MS

Mass spectrometry has been applied to almost every area of research being pursued today. Studies of diverse subjects, such as cancer research, identifica...tion of drugs, forensic analysis, atmospheric end-water environmental analysis, combustion, and lasers have benefited from mass spectrometry. In some of these studies, the mass spectrometer is used both as a chemical reactor and..

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CLINICAL SPECTRUM OF CITRULLINE-A NON ESSENTIAL AMINO ACID PRESENT IN WATERMELON: AN OVERVIEW

Citrulline is a non-essential amino acid, meaning that the body can manufacture it from other nutrients. Within the body, citrulline is converted... to the amino acid L-arginine i.e. citrulline acts as a precursor of amino acid arginine. Some of the proposed uses of citrulline supplements are based on raising levels of arginine. Citrulline also plays a role in a physiological process called “the urea cycle,” in which toxic ammonia is..

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Febrile Status Epilepticus Does Not

Febrile Status Epilepticus Does Not
Cause CSF Pleocytosis in Children
Cerebrospinal fluid findings were normal in
children with febrile status epilepticus and no
central nervous system infection.
To investigate if fever-associated status
epilepticus (FSE) alone causes cerebrospinal
fluid (CSF) pleocytosis, researchers
characterized CSF findings in children
enrolled in the Febrile Status Epilepticu...s
Study, a prospective, multicenter study of
children presenting to one of five emergency
departments (EDs) with FSE but no identified
central nervous system infection or other
pathologic condition. FSE was defined as a
single seizure or a series of seizures without
interim recovery lasting at least 30 minutes
associated with fever >38.4°C.
Of 200 children (age range, 1 month through
5 years; median age, 16 months), 154 (77%)
underwent lumbar puncture (LP) at the
discretion of the ED attending physician.
Children who underwent LP were significantly
younger than those who did not (median age,
15 vs. 23 months), less likely to have had
prior febrile seizures, and more likely to have
longer duration of FSE and presence of
focality. Of 136 children with nontraumatic
LPs (<1000 CSF red blood cells), 126 (93%)
had CSF with 3 white blood cells/mm .
Mean CSF protein and glucose levels were
within normal limits (22 mg/dL and 90 mg/
dL, respectively).
Comment: The authors correctly conclude
that CSF pleocytosis in children with fever-
associated status epilepticus cannot be
attributed to an ictal phenomenon. Children
with FSE and CSF pleocytosis should receive
prompt intravenous antibiotics for potential
bacterial etiologies as well as antivirals for
suspected herpes simplex virus

Extended Treatment After Unprovoked Venous Thromboembolism Apixaban, which is not yet FDA-approved for VTE, lowered recurrence by about 7 percentage points during 1 year.

Extended Treatment After Unprovoked Venous Thromboembolism Apixaban, which is not yet FDA-approved for VTE, lowered recurrence by about 7 percentage points during 1 year.

In patients who have completed courses of initial anticoagulation for unprovoked venous thromboembolism (VTE), extended treatment with warfarin, the oral factor Xa inhibitor rivaroxaban (Xarelto), or (to a lesser extent) aspirin... can lower the rate of recurrence. How does apixaban (Eliquis), another oral factor Xa inhibitor, fare in this regard? In an industry-sponsored randomized trial, 2500 patients who had just completed 6 to 12 months of standard anticoagulation for deep venous thrombosis or pulmonary embolism received twice-daily doses of 5-mg apixaban, 2.5-mg apixaban, or placebo. The qualifying VTE events were unprovoked in 92% of cases.

During 1 year of treatment, the incidence of symptomatic or fatal recurrent VTE was 9% in the placebo group and 2% in both apixaban groups — a significant difference. For several composite endpoints that also included all-cause mortality or arterial thrombotic events, apixaban consistently conferred a 7-to 8-percentage-point advantage over placebo. Rates of major bleeding were lower than 1% in all three groups.

Comment: Apixaban recently was FDA-approved for patients with atrial fibrillation. If it is approved eventually for extended treatment following VTE, it will become another option for patients with this condition. However, several caveats apply: This study lasted for only 12 months, most participants were relatively young (mean age, 57), most had normal renal function, and the drug will be expensive. Studies in which apixaban and alternative therapies are compared directly, and additional data on safety and efficacy in older and sicker patients, would be valuable.

Oxytocin Overuse During Induction: Is Managing with Less Appropriate?

Oxytocin Overuse During Induction: Is Managing with Less Appropriate?

Oxytocin discontinuation during active labor did not raise risk for cesarean delivery, but did lead to longer labor and higher rates of chorioamnionitis.

Although oxytocin is the most widely used agent for inducing labor, optimal regimens for this indication remain unknown. Researchers conducted a trial in 252 pregnant women ...who underwent induction to determine if discontinuing oxytocin during labor affected likelihood of cesarean delivery. Participants were randomized to routine induction (oxytocin administration until delivery) or oxytocin discontinuation at attainment of active labor (defined as regular uterine contractions and cervical dilation

cm).

In fully 25% of patients in the discontinuation group, oxytocin infusion was maintained after active labor was achieved (reasons not always known); moreover, in another 46% of patients in this group, oxytocin had to be restarted after discontinuation (as allowed per study protocol). Therefore, the data were also analyzed by actual treatment received. In that analysis, cesarean birth rates were similar in the discontinuation and routine groups (21% and 23%, respectively). Median duration of active labor was longer in the discontinuation group (4.2 vs. 3.0 hours; P=0.004), and chorioamnionitis was diagnosed more often (15% vs. 6%; P=0.01).

Comment: Despite its limitations (e.g., lack of blinding, continuation or restarting of oxytocin in the discontinuation group), this study is conceptually interesting. Oxytocin is a high-alert medication, and investigating ways to curtail its use is worthwhile. Once active labor is established, oxytocin discontinuation does not seem to alter risk for cesarean delivery; however, it does lead to longer labor and higher rates of chorioamnionitis. Thus, clinicians should carefully assess labor progression in women who might be at risk for chorioamnionitis — and larger, more-rigorous studies are necessary before oxytocin discontinuation during active labor can be approved.

Biogen Idec has announced that its

Biogen Idec has announced that its
EMPOWER Phase III ALS drug trial of
dexpramipexole has failed to meet its
primary endpoint.
Dexpramipexole, a treatment for amyotrophic
lateral sclerosis (ALS), did not meet its
primary endpoint of a joint rank analysis of
function and survival, and no efficacy was
seen in individual components of function or
survival, the drug company announced today.
... The trial also failed to show efficacy in its
key secondary endpoints. As such, Biogen
Idec has said it will abandon development of
dexpramipexole in ALS.
Biogen Idec Research and Development
executive vice president Dr Douglas Williams
said; "We share the disappointment of
members of the ALS community, who had
hoped that dexpramipexole would offer a
meaningful new treatment option.
"Nevertheless, the EMPOWER trial represents
a significant contribution to ALS research,
and Biogen Idec is committed to advancing
ALS science. We continue to work with
researchers around the world to understand
the causes of ALS and find potential
treatments for people with ALS."
The EMPOWER trial was a randomised,
double-blind placebo-controlled Phase III
trial of 943 people with ALS in 81 sites,
covering 11 countries. Patients were
randomised on a one-to-one basis to receive
either dexpramipexole or placebo.
Biogen Idec Neurodegeneration Clinical
Research director Dr Douglas Kerr said; "As
a physician who has treated people with ALS,
I hoped with all my heart for a different
outcome. While these results were not what
we expected, we hope these data will provide
a foundation for future ALS research."
The company intends to present detailed
results at a future medical conference.

The findings expand on previous work done

The findings expand on previous work done
at the University of Michigan, Harvard
University and the City University of New
York where researchers delivered electricity
through sensors on the skulls of chronic
migraine patients, and found a decrease in
the intensity and pain of their headache
attacks. However, the researchers then
couldn't completely explain how or why.
The current findings help ex...plain what
happens in the brain that decreases pain
during the brief sessions of electricity, says
Alexandre DaSilva, assistant professor of
biologic and materials sciences at the U-M
School of Dentistry and director of the
school's Headache & Orofacial Pain Effort
Lab.
In their current study, DaSilva and colleagues
intravenously administered a radiotracer that
reached important brain areas in a patient
with trigeminal neuropathic pain (TNP), a
type of chronic, severe facial pain. They
applied the electrodes and electrically
stimulated the skull right above the motor
cortex of the patient for 20 minutes during a
PET scan (positron emission tomography).
The stimulation is called transcranial direct
current stimulation (tDCS).
The radiotracer was specifically designed to
measure, indirectly, the local brain release of
mu-opioid, a natural substance that alters
pain perception. In order for opiate to
function, it needs to bind to the mu-opioid
receptor (the study assessed levels of this
receptor).
"This is arguably the main resource in the
brain to reduce pain," DaSilva said. "We're
stimulating the release of our (body's) own
resources to provide analgesia. Instead of
giving more pharmaceutical opiates, we are
directly targeting and activating the same
areas in the brain on which they work.
(Therefore), we can increase the power of
this pain-killing effect and even decrease the
use of opiates in general, and consequently
avoid their side effects, including addiction."
Most pharmaceutical opiates, especially
morphine, target the mu-opioid receptors in
the brain, DaSilva says.
The dose of electricity is very small, he says.
Consider that electroconvulsive therapy
(ECT), which is used to treat depression and
other psychiatric conditions, uses amperage
in the brain ranging from 200 to 1600
milliamperes (mA). The tDCS protocol used
in DaSilva's study delivered 2 mA,
considerably lower than ECT.
Just one session immediately improved the
patient's threshold for cold pain by 36
percent, but not the patient's clinical, TNP/
facial pain. This suggests that repetitive
electrical stimulation over several sessions
are required to have a lasting effect on
clinical pain as shown in their previous
migraine study, DaSilva says.
The manuscript appears in the journal
Frontiers in Psychiatry . The group just
completed another study with more subjects,
and the initial results seem to confirm the
findings above, but further analysis is
necessary.
Next, researchers will investigate long-term
effects of electric stimulation on the brain
and find specific targets in the brain that may
be more effective depending on the pain
condition and patients' status. For example,
the frontal areas may be more helpful for
chronic pain patients with depression
symptoms.

Prof. Michael Gurevitz of Tel Aviv

Prof. Michael Gurevitz of Tel Aviv
University's Department of Plant Sciences is
investigating new ways for developing a novel
painkiller based on natural compounds found
in the venom of scorpions. These compounds
have gone through millions of years of
evolution and some show high efficacy and
specificity for certain components of the body
with no side effects, he says.
Peptide toxins found in scor...pion venom
interact with sodium channels in nervous and
muscular systems -- and some of these
sodium channels communicate pain, says
Prof. Gurevitz. "The mammalian body has
nine different sodium channels of which only
a certain subtype delivers pain to our brain.
We are trying to understand how toxins in the
venom interact with sodium channels at the
molecular level and particularly how some of
the toxins differentiate among channel
subtypes.
"If we figure this out, we may be able to
slightly modify such toxins, making them
more potent and specific for certain pain
mediating sodium channels," Prof. Gurevitz
continues. With this information, engineering
of chemical derivatives that mimic the
scorpion toxins would provide novel pain
killers of high specificity that have no side
effects.
An ancient Chinese secret?
In his research, Prof. Gurevitz is
concentrating on the Israeli yellow scorpion,
one of the most potent scorpions in the
world. Its venom contains more than 300
peptides of which only a minor fraction has
been explored. The reason for working with
this venom, he says, is the large arsenal of
active components such as the toxins that
have diversified during hundreds of millions
of years under selective pressure. During that
process, some toxins have evolved with the
capability to directly affect mammalian
sodium channel subtypes whereas others
recognize and affect sodium channels of
invertebrates such as insects. This deviation
in specificity is for us a lesson of how toxins
may be manipulated at will by genetic
engineering, he says.
While the use of scorpion venom to treat
some body disorders seems counter-intuitive,
the Chinese have recognized its effectiveness
hundreds of years ago. "The Chinese, major
practitioners of what we call 'alternative
medicine,' use scorpion venom, believing it to
have powerful analgesic properties," Prof.
Gurevitz says. Some studies have also
shown that scorpion venom can be used to
treat epilepsy. "We study how these toxins
pursue their effects in the Western sense to
see how it could be applied as a potent
painkiller."
Using an approach called "rational design" or
"biomimicry," Prof. Gurevitz is trying to
develop painkillers that mimic the venom's
bioactive components. The idea is to use
nature as the model, and to modify elements
of the venom so that a future painkiller
designed according to these toxins could be
as effective as possible, while eliminating or
reducing side effects.
No more morphine addicts
Finding a new and effective pain medication
could solve one of the biggest problems in
the medical world today. Pain is an important
physiological response to danger, physical
injury and poor health, yet doctors need to
reduce extreme pain in patients which aspirin
could never palliate. To date, opiate-derived
painkillers have been quite effective, but the
medical community is eager to find other
solutions due to the risks associated with
their use.
"This new class of drugs could be useful
against serious burns and cuts, as well as in
the military and in the aftermath of
earthquakes and natural disasters. Instead of
running the risk of addiction, this venom-
derived drug, mimicking the small peptide
toxin, would do what it needs to do and then
pass from the body with no traces or side-
effects

The Risk for Melanoma in Large, Congenital Melanocytic Nevi After LCMN surgery, the risk for malignant transformation is reduced but not negligible, and scarring may affect cosmetic improvement.

The Risk for Melanoma in Large, Congenital Melanocytic Nevi After LCMN surgery, the risk for malignant transformation is reduced but not negligible, and scarring may affect cosmetic improvement.

Congenital melanocytic nevi (CMN) occur in 1% of newborns. CMN are classified by projected adult size: small (<1.5 cm), medium (1.5 to 19.9 cm), and large (>20 cm). Large CMN (LCMN) are rare (occurring in... 1/20,000 to 1/500,000 newborns) and are associated with a higher risk for melanoma than smaller CMN, but the true risk is unknown, and optimal management of LCMN is controversial.

Investigators evaluated 14 studies of LCMN performed during the period 1966 through 2011 that had at least 20 subjects. Among 2578 patients, 52 melanomas arose in 51 patients (2%). Age at melanoma diagnosis ranged from birth to 58 years (mean age, 12.6 years); 55% were fatal (mean age at death, 10 years; range, 0.9 to 40 years). Location was specified in 44 patients. The primary melanomas were cutaneous in 37 patients (82%), including 30 (68%) that were truncal; 7 were visceral (central nervous system, 4; bone marrow, 1; retroperitoneal, 1; dorsal muscle, 1). Among 38 LCMN with size reported, 28 were larger than 40 cm (74%); 11 (29%) were 60 cm. Satellite nevi were found in 32 patients. Melanoma incidence was estimated at 2.3 per 1000 patient-years.

The authors report that the psychosocial burden of LCMN was difficult for patients and parents, but the psychosocial benefits of surgical excision were mixed.

Comment: Although the analysis was limited somewhat by selection bias and by heterogeneity of the included studies, this systematic review demonstrates that melanoma incidence in large congenital melanocytic nevi is lower than has been historically believed. However, the risk is significantly higher for patients with CMN larger than 40 cm. In these patients, LCMN-related melanoma usually arose in childhood, and mortality was high. Nevus excision did not fully eliminate the risk — 14% of melanomas arose in visceral sites. Insufficient data were available to determine the medical and psychosocial value of prophylactic excision of LCMN.

Large, long-term, prospective studies from the U.K. have shown that surgical excision of small CMN of the head and neck produced high patient satisfaction. In contrast, tissue expansion/excision for LCMN was associated with more regrowth at surgical margins and more satellitosis, and 11% to 14% of patients with LCMN believed that surgery worsened their appearance (Br J Dermatol 2009; 160:387).

Interferon-Free Regimens for Chronic HCV Infection: Getting Closer

A major drawback of current therapies for chronic hepatitis C virus (HCV) infection is poor tolerability of adverse effects, mainly caused by peginterferon. Previous studies of interferon-free HCV regimens were early phase trials (JW Gastroenterol Jan 18 2012 and JW Gastroenterol Sep 30 2011); now results are available from two industry-sponsored, open-label, phase 2a trials in patients with HCV genotypes 1, 2, and 3.
In the first study, investigators randomized 40 treatment-naive patients with genotype 2 or 3 in a 1:1:1:1 ratio to four groups, all of which received sofosbuvir — an oral nucleotide HCV polymerase inhibitor — (400 mg daily) and ribavirin (1000–1200 mg daily) for 12 weeks. Three groups also received peginterferon (180 µg weekly) for 4, 8, and 12 weeks, respectively. Subsequently added study groups included the following: 10 patients with genotypes 2 or 3 who received sofosbuvir monotherapy for 12 weeks; 10 patients with genotypes 2 or 3 who received sofosbuvir, ribavirin, and peginterferon for 8 weeks; and 25 genotype 1, treatment-naive patients and 10 genotype 1 null responders to previous peginterferon/ribavirin treatment who received sofosbuvir and ribavirin for 12 weeks. The primary end point of sustained virologic response at 24 weeks post-therapy was achieved by all 40 patients who received sofosbuvir plus ribavirin with or without peginterfero n, 6 of the 10 patients who received sofosbuvir monotherapy, 21 of the 25 genotype 1, treatment-naive patients who received sofosbuvir and ribavirin, and only 1 of the 10 genotype 1, treatment-experienced patients who received sofosbuvir and ribavirin. No mutations were observed in the other 9 patients. Adverse effects were mild.
In the second study, investigators sequentially enrolled patients with HCV genotype 1. All patients received ABT-333 — a nonnucleoside NS5B polymerase inhibitor — (400 mg twice daily), ribavirin (1000–1200 mg daily), and one of two daily doses of ABT-450/r (ABT-450, an NS3 protease inhibitor, combined with 100 mg of ritonavir daily) for 12 weeks. Groups of 19 and 14 treatment-naive patients received 250 mg and 150 mg of ABT-450/r, respectively, and a third group of 17 treatment-experienced patients received 150 mg of ABT-450/r. The primary end point was extended rapid virologic response (undetectable HCV RNA from weeks 4 through 12), which was achieved in 89%, 79%, and 59% of the three groups, respectively. Sustained virologic response was achieved in 95%, 93%, and 47%, respectively. Resistant variants in NS3 and NS5B were observed in 8 of the 9 patients who had virologic failure in group three. Side effects were mild.
Comment: These findings suggest that we are close to realizing the ideal HCV treatment — an interferon-free, simple regimen of short duration with minimal adverse effects and low resistance rates. Patients with genotypes 2 or 3 and treatment-naive patients with genotype 1 will be the first to benefit. Ribavirin seems to be here to stay, at least for now. Unfortunately, difficult-to-treat patients such as genotype 1, treatment-experienced patients will likely continue to require interferon as part of their regimens.

2013: Making internationalisation more than just a numbers game

Introducing the new year in University World News with a wish list for 2013, in World Blog Hans de Wit writes that many would like to see a greater emphasis on the content and quality of the international experience rather than just numbers. Yojana Sharma reports on the global move away from raising literacy levels and basic access, towards skills required by the workforce to promote economic growth. Two reports by Alya Mishra on the New Delhi r ape case that rocked India in late 2012 show that it may well prove to be the beginning of a long overdue effort to support and strengthen the position of women at Indian universities. From the United States, Alison Moodie writes that the authorities appear to be recognising that a globalised world requires its graduates to have truly global world views – and have released, for the first time, an international strategy. In Commentary, Glen A Jones argues that 2012 was a year of living dangerously for higher education in Ontario, Canada, as a new minister pushed for reform. From the same country, Abu Kamara comments on Canada’s efforts to increase the internationalisation of higher education for its own future prosperity. And from Europe, Anne Corbett asks whether the 30-year-old European Students’ Union can confront the democratic deficit at the heart of the European Higher Education Area.

Don't let hand pain hold you back Find out how you can control and quell the effects of arthritis, "pinched" nerves, and other hand ailments and injuries



Healthy hands perform countless small tasks, from pouring coffee in the morning to brushing teeth at night. But aching hands can transform even these simple tasks into painful ordeals.

Hands may hurt for a variety of reasons. Arthritis is the most common cause of hand pain and disability. Carpal tunnel syndrome can make it difficult to make a fist or grasp a pen. Tendon injuries can leave fingers bent and cramped.

Fortunately, almost every hand problem can be successfully treated. Pain can be significantly reduced. Dexterity can be regained.

In Hands: Strategies for strong pain-free hands, the doctors at Harvard Medical School will give you an empowering understanding of your hands' mechanics, the diseases that compromise function, and, most important, what you can do to ease the aches, restore range-of-motion, and prevent problems from recurring.

If you experience arthritis, you are not alone — it affects one in five adults. The report will give you recommendations for treating arthritis. You'll learn how the most popular topical and oral medications compare. You'll be alerted to the dangers of steroids. And you'll be briefed on complementary treatments that are offering positive results in decreasing pain and increasing mobility.

Hands dispels the myths about carpal tunnel syndrome. You'll find out why computer use may actually lower your risk. You'll learn how to distinguish carpal tunnel from other "pinched" nerve syndromes. And you'll discover a host of treatment options, including a surgical technique for this problem with a 90% success rate.

The report will tell you what causes "cold hands," how "trigger finger" comes about, describe a cure for "writer's cramp" and a new injection that's replacing surgery to treat Dupuytren's contracture. It also gives you the key questions to ask yourself — and your doctor — before considering joint replacement surgery.

The report will also give you guidance for treating a fracture or dislocation.

In addition, you'll find a dozen exercises for the hand, plus a guide to more than 40 tools that can make life easier when pain occurs.

So, enjoy life hands on! Order your copy of Hands: Strategies for strong pain-free hands now!

To your good health,

Pharma guidelines new updates

TOC Analyzer
Ø Ensurethat the instrument is in calibrated
condition before use.
Ø Ensureall the connections of the
instrument are proper before use.
Ø Opencarrier gas used for TOC (Zero air
cylinder) with cylinder pressure and gas
line pressure maintained at 4-6 Kg/cm2.
Ø Thepressure of the carrier gas i.e. Zero
air should be 2 Kg/cm2 (200kpa) and flow
should be 150 ml/min.Adjust if necessary by
opening the front doorand adjusting gas
pressure controller and mass flow controller.
Ø Ensurelevel of the water in the humidifier
should be kept between two marks shown
on the bottle i.e. between(High and Low
mark).
Ø Getthe raw data (printout) of the analysis
checked.
·        Disintegration test Apparatus
Ø Ensurethat the instrument s in calibrated
condition before use.
Ø Ensureall the connections of the
instrument are proper before use.
Ø Ensure,the bath is filled with water up to
the level marked (without beakers)
Ø Setthe temperature to 37oC unless
otherwise specified.
Ø Cleanthe basket rack assembly, beakers,
and discs after use.
·        Friabilator
Ø Ensurethat the instrument s in calibrated
condition before use.
Ø Ensureall the connections of the
instrument are proper before use.
Ø Fortablets with a unit weight equal to or
less than 650 mg, take a sample of whole
tablets corresponding as nearas possible to
6.5 g. For tabletswith a unit weight of
more than 650 mg, take a sample of 10
whole tablets.
Ø Thetablets should be carefully dedusted
prior to testing.
Ø Accuratelyweigh the tablet sample, and
place the tablets in the drum. After
testing remove the tablets. Remove any
loose dustfrom the tablets as before,
andaccurately weigh.
Ø Afterconducting friability test, weighing of
the tablets shall be done within 15minutes.
·        Statistical tools for evaluation of data
Ø Meanand Standard deviation:
Mean(arithmetic mean) is given by the
formula
x
=
X1 + x2 + x3 + ……. xn-1 + xn
n
Standard deviation (S), isgiven by the
formula
S
=
∑ (x - x)2
n-1
Relativestandard deviation (RSD), is given by
formula
RSD
=
S
x
Ø Comparisonof results
Thecomparison of the values obtained from
a set of results with either the truevalue or
with other sets of data makes it possible to
determine whether theanalytical procedure
has been accurate and / or precise, or if it is
superiorto another method. There are two
common method for comparing results,
Student’st-test and the variance ratio test
(F-test).
Student’st-test
This is the test used forsmall samples; its
purpose is to compare the mean from a
sample with somestandard value and to
express some level of confidence in the
significance ofthe comparison. It is also
used to test the difference between the
means of twosets of data x1 and x2.
The value of t is obtainedfrom the equation
t
=
( x - µ)
n
s
Whereµ is the true value.
F-test
Thisis used to compare the precisions of two
sets of data, e.g. the results of twodifferent
analytical methods or the results from two
different laboratories. Itis calculated from
the equation
F
=
S2A
S2B
Thelarger value of S is always used as the
numerator, so the value of F is
alwaysgreater than unity.
Ø Comparingthe means of two samples
Whena new analytical method is being
developed it is usual practice to compare
thevalues of the mean and precision of the
new (test) method with those of
anestablished (reference) procedure.
The value of t whencomparing two sample
means x1 and x2 is given by theexpression
t
=
x1- x2
Sp 1/n1 + 1/n2
WhereSp, the pooled standard deviation, is
calculated from the two samplestandard
deviations S1 and S2, as follows:
Sp
=
(n1-1)s21 + (n2-1)s22
n1 + n2 - 2
Notethat there must not be a significant
difference between the precisions of
themethods. Hence the F-test is applied
before using the t-test in equation.
Whenusing instrumental methods it is often
necessary to carry out a
calibrationprocedure by using a series of
samples (standards) each having a
knownconcentration of the analyte to be
determined. A calibration curve
isconstructed by measuring the instrumental
signal for each standard and plottingthis
response against concentration. Provided the
same experimental conditionsare used for
the measurement of the standards and for
the test (unknown)sample, the
concentration of the testsample may be
determined from the calibration curve by
graphical interpolation.
Correlationcoefficient
Toestablish whether there is a linear
relationship between two variables x1and
y1, use Pearson’s correlation coefficient r:
r
=
n∑ x1y1 - ∑x1∑y1
{[n∑x21 – (∑x1)2][n∑y21 –(∑y1)2]}1/2
Wheren is the number of data points.
Thevalue of r must lie between +1 and -1;
the nearer it is to ± 1, the greater
theprobability that a definite linear
relationship exists between the variables
xand y; values close to +1 indicate positive
correlation and values close to -1indicate
negative correlation. Values of r that tend
towards zero indicate thatx and y are not
linearly related (they may be related in a
non-linear fashion).
· Microbiologytesting
Ø Usecorrect incubation period and
temperature specified in the method of
analysis.
Ø Ensurethat the growth promotion test is
performed for the media to be used
foranalysis.
Ø Takeall required precautions while
handling the Microbiological cultures.
Ø Ensurethat the Microscope is calibrated
and working properly.
Ø Ensurethat all the glassware's used for
microanalysis are decontaminated properly.
Ø Culture/ suspending / sub culturing
should be traceable.
· Generalprecaution
Precautions:
Ø Crosscheckthe exactness of instrument
method / program & sequence with respect
to themethod of analysis.
Ø Crosscheckthe exactness of sequence
with respect to the samples loaded in auto
sampler.
Ø Alwayscompare response obtained with
previous data as a tool of crosscheck.
Ø Usecorrect excel sheet for calculation.
Ø Avoidglassware breakage. Upon breakage
of any glassware intimate to your
respectivesupervisor so that the requirement
for the same can be raised to avoid
shortageof glassware.
Ø Keepthe allocated samples in the
respective designated area during and
afteranalysis duly labeled.
Ø Recordthe temperature and humidity of
the areas daily once and intimate to
immediatesupervisor if any excursion is
observed for more than half an hour.
· Interpretation
Ø Interpretationshould be aligned with the
requirements in the method of analysis.
Ø Interpretationshould be done by
considering the category of the method e.g.
Relatedsubstances, assay etc.
Ø Donot use manual integration events for
quantification method unless
otherwisespecified in the method.
Ø Comparethe chromatographic data with
specimen chromatogram.
Ø Ifthe results are not as per trend then
inform immediately to immediatesupervisor.
· Records& Reports
Ø Recordthe values & results online.
Ø Checkthe entered values & figures for
correctness online.
Ø Calculatethe results using correct
formulae (as per method of analysis) &
recheckonce online.
Ø Donot overwrite the wrong entry. Cross it
out with a line permitting the readingof
original entry. Clearly write the correct entry
near the cross out &sign the data along with
the date on which correction is made.
Ø Donot leave the blank spaces. Draw a line
across the page from left to right.
Ø Allthe document entries shall be made
with indelible black ink in clear &legible
hand writing.
Ø Columnsor rows not required shall be
marked as ‘N.A.’ or ‘—’.
Ø Validateexcel sheet whenever required for
calculation of results of CU/BU &dissolution
(Profile/ Single point).
Ø Usecorrect path of validated excel sheet
for calculation of results.
Ø Ensurethat the usage and consumption
entry is made in the respective instrument
andcolumn log book and working standard
log book respectively.
Ø Ensurethat the respective index is updated
when any SOP/ Document is created /
revised.

Pharma guidelines new updates

TOC Analyzer
Ø Ensurethat the instrument is in calibrated
condition before use.
Ø Ensureall the connections of the
instrument are proper before use.
Ø Opencarrier gas used for TOC (Zero air
cylinder) with cylinder pressure and gas
line pressure maintained at 4-6 Kg/cm2.
Ø Thepressure of the carrier gas i.e. Zero
air should be 2 Kg/cm2 (200kpa) and flow
should be 150 ml/min.Adjust if necessary by
opening the front doorand adjusting gas
pressure controller and mass flow controller.
Ø Ensurelevel of the water in the humidifier
should be kept between two marks shown
on the bottle i.e. between(High and Low
mark).
Ø Getthe raw data (printout) of the analysis
checked.
·        Disintegration test Apparatus
Ø Ensurethat the instrument s in calibrated
condition before use.
Ø Ensureall the connections of the
instrument are proper before use.
Ø Ensure,the bath is filled with water up to
the level marked (without beakers)
Ø Setthe temperature to 37oC unless
otherwise specified.
Ø Cleanthe basket rack assembly, beakers,
and discs after use.
·        Friabilator
Ø Ensurethat the instrument s in calibrated
condition before use.
Ø Ensureall the connections of the
instrument are proper before use.
Ø Fortablets with a unit weight equal to or
less than 650 mg, take a sample of whole
tablets corresponding as nearas possible to
6.5 g. For tabletswith a unit weight of
more than 650 mg, take a sample of 10
whole tablets.
Ø Thetablets should be carefully dedusted
prior to testing.
Ø Accuratelyweigh the tablet sample, and
place the tablets in the drum. After
testing remove the tablets. Remove any
loose dustfrom the tablets as before,
andaccurately weigh.
Ø Afterconducting friability test, weighing of
the tablets shall be done within 15minutes.
·        Statistical tools for evaluation of data
Ø Meanand Standard deviation:
Mean(arithmetic mean) is given by the
formula
x
=
X1 + x2 + x3 + ……. xn-1 + xn
n
Standard deviation (S), isgiven by the
formula
S
=
∑ (x - x)2
n-1
Relativestandard deviation (RSD), is given by
formula
RSD
=
S
x
Ø Comparisonof results
Thecomparison of the values obtained from
a set of results with either the truevalue or
with other sets of data makes it possible to
determine whether theanalytical procedure
has been accurate and / or precise, or if it is
superiorto another method. There are two
common method for comparing results,
Student’st-test and the variance ratio test
(F-test).
Student’st-test
This is the test used forsmall samples; its
purpose is to compare the mean from a
sample with somestandard value and to
express some level of confidence in the
significance ofthe comparison. It is also
used to test the difference between the
means of twosets of data x1 and x2.
The value of t is obtainedfrom the equation
t
=
( x - µ)
n
s
Whereµ is the true value.
F-test
Thisis used to compare the precisions of two
sets of data, e.g. the results of twodifferent
analytical methods or the results from two
different laboratories. Itis calculated from
the equation
F
=
S2A
S2B
Thelarger value of S is always used as the
numerator, so the value of F is
alwaysgreater than unity.
Ø Comparingthe means of two samples
Whena new analytical method is being
developed it is usual practice to compare
thevalues of the mean and precision of the
new (test) method with those of
anestablished (reference) procedure.
The value of t whencomparing two sample
means x1 and x2 is given by theexpression
t
=
x1- x2
Sp 1/n1 + 1/n2
WhereSp, the pooled standard deviation, is
calculated from the two samplestandard
deviations S1 and S2, as follows:
Sp
=
(n1-1)s21 + (n2-1)s22
n1 + n2 - 2
Notethat there must not be a significant
difference between the precisions of
themethods. Hence the F-test is applied
before using the t-test in equation.
Whenusing instrumental methods it is often
necessary to carry out a
calibrationprocedure by using a series of
samples (standards) each having a
knownconcentration of the analyte to be
determined. A calibration curve
isconstructed by measuring the instrumental
signal for each standard and plottingthis
response against concentration. Provided the
same experimental conditionsare used for
the measurement of the standards and for
the test (unknown)sample, the
concentration of the testsample may be
determined from the calibration curve by
graphical interpolation.
Correlationcoefficient
Toestablish whether there is a linear
relationship between two variables x1and
y1, use Pearson’s correlation coefficient r:
r
=
n∑ x1y1 - ∑x1∑y1
{[n∑x21 – (∑x1)2][n∑y21 –(∑y1)2]}1/2
Wheren is the number of data points.
Thevalue of r must lie between +1 and -1;
the nearer it is to ± 1, the greater
theprobability that a definite linear
relationship exists between the variables
xand y; values close to +1 indicate positive
correlation and values close to -1indicate
negative correlation. Values of r that tend
towards zero indicate thatx and y are not
linearly related (they may be related in a
non-linear fashion).
· Microbiologytesting
Ø Usecorrect incubation period and
temperature specified in the method of
analysis.
Ø Ensurethat the growth promotion test is
performed for the media to be used
foranalysis.
Ø Takeall required precautions while
handling the Microbiological cultures.
Ø Ensurethat the Microscope is calibrated
and working properly.
Ø Ensurethat all the glassware's used for
microanalysis are decontaminated properly.
Ø Culture/ suspending / sub culturing
should be traceable.
· Generalprecaution
Precautions:
Ø Crosscheckthe exactness of instrument
method / program & sequence with respect
to themethod of analysis.
Ø Crosscheckthe exactness of sequence
with respect to the samples loaded in auto
sampler.
Ø Alwayscompare response obtained with
previous data as a tool of crosscheck.
Ø Usecorrect excel sheet for calculation.
Ø Avoidglassware breakage. Upon breakage
of any glassware intimate to your
respectivesupervisor so that the requirement
for the same can be raised to avoid
shortageof glassware.
Ø Keepthe allocated samples in the
respective designated area during and
afteranalysis duly labeled.
Ø Recordthe temperature and humidity of
the areas daily once and intimate to
immediatesupervisor if any excursion is
observed for more than half an hour.
· Interpretation
Ø Interpretationshould be aligned with the
requirements in the method of analysis.
Ø Interpretationshould be done by
considering the category of the method e.g.
Relatedsubstances, assay etc.
Ø Donot use manual integration events for
quantification method unless
otherwisespecified in the method.
Ø Comparethe chromatographic data with
specimen chromatogram.
Ø Ifthe results are not as per trend then
inform immediately to immediatesupervisor.
· Records& Reports
Ø Recordthe values & results online.
Ø Checkthe entered values & figures for
correctness online.
Ø Calculatethe results using correct
formulae (as per method of analysis) &
recheckonce online.
Ø Donot overwrite the wrong entry. Cross it
out with a line permitting the readingof
original entry. Clearly write the correct entry
near the cross out &sign the data along with
the date on which correction is made.
Ø Donot leave the blank spaces. Draw a line
across the page from left to right.
Ø Allthe document entries shall be made
with indelible black ink in clear &legible
hand writing.
Ø Columnsor rows not required shall be
marked as ‘N.A.’ or ‘—’.
Ø Validateexcel sheet whenever required for
calculation of results of CU/BU &dissolution
(Profile/ Single point).
Ø Usecorrect path of validated excel sheet
for calculation of results.
Ø Ensurethat the usage and consumption
entry is made in the respective instrument
andcolumn log book and working standard
log book respectively.
Ø Ensurethat the respective index is updated
when any SOP/ Document is created /
revised.