31 December, 2010
GPAT-2011 SYLLABUS
PHARMACEUTICS
- Introduction to Physical pharmacy; Matter, Properties of Matter:
- State of matter, change in the state of matter, latent heats and vapor pressure, sublimation-critical point, Eutectic mixtures, gases, aerosols-inhalers, relative humidity, liquid. complexes, liquid crystals, glassy state, solids- crystalline, amorphous and polymorphism.
- Micromeretics and Powder Rheology:
- Particle size and distribution, average particle size, number and weight distribution, particle number, methods for determining particle volume, methods of determining particle size- optical microscopy, sieving, sedimentation; measurements of particle shape, specific surface area; methods for determining surface area; permeability, adsorption, derived properties of powders, porosity, packing arrangement, densities, bulkiness & flow properties.
- Surface and Interfacial Phenomenon:
- Liquid interface, surface and interfacial tensions, surface free energy, measurement of surface and interfacial tensions, spreading coefficient, adsorption at liquid interfaces, surface active agents, HLB classification, solubilization, detergency, adsorption at solid interfaces, solid-gas and solid-liquid interfaces, complex films, electrical properties of interface.
- Viscosity and Rheology:
- Newtonian systems, Law of flow, kinematic viscosity, effect of temperature; non-Newtonian systems: pseudoplastic, dilatant, plastic; thixotropy, thixotropy in formulation, negative thixotropy, determination of viscosity, capillary, falling ball, rotational viscometers.
- Dispersion Systems:
- Colloidal dispersions: Definition, types, properties of colloids, protective colloids, applications of colloids in pharmacy; Suspensions and Emulsions: Interfacial properties of suspended particles, settling in suspensions, theory of sedimentation, effect of
Propoxyphene Withdrawn From US Market
Courtesy:US FDA
Source: Medscape Medical News
November 19, 2010 — The US Food and Drug Administration (FDA) has asked that propoxyphene, sold under the brand names Darvonand Darvocet by Xanodyne Pharmaceuticals, be removed from the US market. The decision will also affect generic manufacturers and the makers of propoxyphene-containing products.
New clinical data showing that the drug puts patients at risk for potentially serious or even fatal heart rhythm abnormalities has prompted regulators to act. An estimated 10 million patients have used these products.
At a press conference today, John Jenkins, MD, director of the Office of New Drugs, said the new numbers tipped the risk–benefit ratio against the drug.
The withdrawal will include brand name, generic, and all propoxyphene-containing products.
"For the first time, we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart," said Gerald Dal Pan, MD, director of the Office of Surveillance and Epidemiology.
The FDA is advising healthcare professionals stop prescribing propoxyphene. Patients who are currently taking the drug should not abruptly halt their medication but should contact their physician as soon as possible to discuss switching to another pain-management therapy.
"Long-time users of the drug need to know that these changes to the heart's electrical activity are not cumulative," Dr. Dal Pan added. "Once patients stop taking propoxyphene, the risk will go away."
Propoxyphene is an opioid typically used to treat mild to moderate pain. It was first approved by the FDA in 1957. It is sold by prescription under various names alone or in combination with acetaminophen. Since 1978, the FDA has received 2 requests to remove propoxyphene from the market.
In January 2009, an FDA advisory committee voted 14 to 12 against the continued marketing of propoxyphene products. At that time, the committee called for additional information about the drug's cardiac effects.
Withdrawal Already Underway in Europe
A phased withdrawal of propoxyphene is already underway in Europe. The European Medicines Agency made that decision in June 2009. The FDA had considered a withdrawal last year but decided instead to allow continued marketing with a new boxed warning alerting patients and healthcare professionals of the risk for fatal overdose. The agency also required Xanodyne to conduct a new safety study assessing questions about the effects of propoxyphene on the heart.
The results of this study, combined with new epidemiologic data and medical examiner reports, prompted this latest regulatory action.
Should the FDA have acted sooner? Dr. Dal Pan told Medscape Medical News that regulators did not feel there was sufficient evidence before now. "The new information on the effects of the electrical activity on the heart was the final piece to the puzzle," he said.
"These new heart data significantly alter propoxyphene's risk–benefit profile," Dr. Jenkins added. "The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks."
30 December, 2010
GPAT-2010 Questions With Answer Key
Q.l The vitamin essential in tissue culture medium is
(A) Pyridoxine (B) Thiamine (C) Nicotinic acid (D) Inositol
Ans. B
Q.2 Gingkgo biloba is used for its
(A) Expectorant activity (B) Lipid lowering activity
(C) PAF antagonistic activity (D)Antidepressant activity
Ans. C
Q.3 The amount of barbaloin present in Aloe vera is
(A) <1% (B) 3.5-4% (c) 1-1.5% (D) 2-2.5%
Ans. B
Q.4 Sildenafil is used for treatment of one of the following disorders :
(A) Systolic hypertension (B) Unstable angina
(C) Pulmonary hypertension (D) Hypertension due to eclampsia
Ans. C
Q.5 Cardiac glycosides have the following configuration in the aglycone part of the steroid nucleus :
(A) 5a, 1 4 a - 5a, 14β- (C) 5β, 1 4 a - (D) 5β,14β-
Ans. D
Q.6 Quassia wood is adulterated with
(A) Brucea antidysentrica (B) Cassia angustifoila
C) Cinnamomum zeylanicum (D) Cephaelis ipecacuanaha
Ans. B
Q.7 Eugenol is present in
(A) Fennel (B) Tulsi (C) Cardamom (D) Coriander
Ans. B
Q.8 Which one of the following drugs is prescribed for the treatment of Philadelphia chromosome positive
patients with Chronic myeloid Leukemia?
(A) Pentostatin (B) Methotrexate
(C) Imatinib (D) L-Asparaginase
Ans. C
Q.9 Which of the following monoclonal antibodies is prescribed for patients with non-Hodgkin's
Lymphoma?
(A) Infliximab (B) Abciximab (C) Gemtuzumab (D) Rituximab
Ans.
Q.10 Identify the drug which is NOT used in the treatment of malaria caused by Plasmodium falciparum :
(A.) Artemisinin (B) Primaquine (C) Quinine (D) Mefloquine
Ans. B
Q.ll Which one of the following drugs does NOT act through G-Protein coupled receptors?
(A) Epinephrine (B) Insulin (C) Dopamine (D) TSH
Ans. B
Q.12 Which one of the following drugs is most effective in preventing transmission of HIV virus from the mother
to the foetus?
(A) Lamivudine (B) Zidovudine (C) Indinavir (D) Ribavirin
Ans. B
Q.13 Improvement of memory in Alzheimer's disease is brought about by drugs which increase transmission in
(A) cholinergic receptors (B) dopaminergic receptors
(C) GABAergic receptors (D) adrenergic receptors
Ans. A
Q.14 Which of the following non-opioid analgesics is a prodrug?
(A) Piroxicam (B) Celecoxib (C)Nabumetone (D) Ketorolac
Ans. C
Q.15 Which one of the following drugs is NOT a typical anti-psychotic agent?
(A) Chlorpromazine (B) Haloperidol
(C) Risperidone (D) Flupentixol
Ans. C
Q.16 Which one of the followings is a plasminogen activator?
(A) Tranexamic acid (B) Streptokinase
(C) Aminocaproic acid (D) None of the above
Ans. B
Q.17 Myasthenia gravis is diagnosed with improved neuromuscular function by using
(A) Donepezil (B) Edrophonium (C) Atropine (D) Pancuronium
Ans. B
Q.18 Which one of the following drugs specifically inhibits calcineurin in the activated T lymphocytes?
(A) Daclizumab (B) Prednisone (C) Sirolimus (D) Tacrolimus
Ans. D
Q.19 The chemical behaviour of morphine alkaloid is
(A) acidic (B)Basic (C) neutral (D) amphoteric
Ans. B
Q.20 At physiological pH the following compound would be MOSTLY in the
(A) cationic form (B) unionized form
(C)zwitterionic form (D) anionic form
Ans.
Q.21 Which one of the followings is used as a mood stabilizer for bipolar disorder and also in certain epileptic
convulsions?
(A) Phenytoin (B) Lithium
(C) Sodium valproate (D) Fluoxetine
Ans. B
Q.22 An isosteric replacement for carboxylic acid group is
(A) pyrrole (B) isoxazole (C) phenol (D) tetrazole
Ans.-D
Q.23 The given antibiotic is an example of ansamycins :
(A) Roxythromycin (B) Adriamycin (C) Aureomycin (D) Rifamycin
Ans. D
Q.24 For glyburide, all of the following metabolic reactions are logical EXCEPT
(A) O-demethylation (B) aromatic oxidation
(C) benzylic hydroxylation (D) amide hydrolysis
Ans. B
Q.25 The effects observed following systemic administration of levodopa in the treatment of Parkinsonism have
been attributed to its catabolism to dopamine. Carbidopa, can markedly increase the proportion of levodopa that
crosses the blood-brain barrier by
(A) increasing penetration of levodopa through BBB by complexation with it
(B) decreasing peripheral metabolism of levodopa
(C) decreasing metabolism of levodopa in the CNS
(D) decreasing clearance of levodopa from the CNS
Ans. B
Q.26 Ethambutol molecule has
(A) two chiral centers and 3 stereoisomers
( B) two chiral centers and 4 stereoisomers
(C) two chiral centers and 2 stereoisomers
(D) one chiral center and 2 stereoisomers
Ans. B
Q.27 A compound will be sensitive towards IR radiation only when one of the following properties undergo
transition on
(A) Polarizability (B) Dielectric constant
(C) Dipole moment (D) Refractivity
Ans. C
Q.28 X-ray crystallographic analysis of an optically active compound determines its
(A) Optical rotatory dispersive power (B) Absolute configuration
(C) Relative configuration (D) Optical purity
Ans.
Q.29 Which one of the following statements is WRONG?
(A) A singlet or triplet state may result when one of the electrons from the HOMO is
excited to higher energy levels
(B) In an excited singlet state, the spin of the electron in the higher energy orbital is
paired with the electron in the ground state orbital
(C) Triplet excited state is more stable than the singlet excited state
(D) When the electron from the singlet excited state returns to ground state, the molecule always shows
fluorescence phenomenon
Ans. C
Q.30 Aminotransferases usually require the following for their activity :
(A) Niacinamide (B)Vitamin B12
(C) Pyridoxal phosphate (D) Thiamine
Ans. C
29 December, 2010
Pharmacist: Key Role player in Clinical Research
Author: Dr Sumit Shrivastav, CRAA
Pharmacists are professionals who best understand the nature of a drug inside human body. Typically, pharmacists routinely review medication orders, prescriptions, and medication profiles to ensure appropriate drug selection, doses, and dosing schedule. They look for drug-food interactions that may be harmful. If they identify a drug related problem or detect a potentially dangerous situation, they are responsible for notifying the doctor, patient, or both, and recommend potential alternatives.
This specific skill of pharmacists makes them desirable in clinical research industry. Their knowledge is very helpful in documenting any adverse event related or not related to the drug during the conduct of a trial.
Let’s take a deeper look at how pharmacists fit into clinical research:
Pharmacy Graduates have an added advantage:
As mentioned, a pharmacy graduate has a better understanding of the medical and scientific terminologies used in the pharmaceutical research industry and hence has an edge over other graduates entering the field.
Additionally a pharmacy candidate can understand the importance of any drug-drug interaction, variation in dosing schedule and problem told by a patient. He/she thus proves to be a helping hand in drug development and research process, working along with clinical investigator in proper execution of the trial or working with a sponsor in development of clinical protocol.
Getting a Good start:
Most of the pharmacists start their career dispensing pills at a local pharmacy. Some pharmacists also become directors and part of a new product development at various pharmaceutical companies distributing experimental drugs for clinical trials. In essence, pharmacists help coordinate the research and development process that brings new medication from the laboratory to the familiar pharmacist shelf.
Career Opportunities for Pharmacists in Clinical Research:
An entry level to most of the pharmacy graduates to enter into the clinical research industry is as Clinical Research Coordinator or Clinical Research Associate.
A clinical research coordinator (CRC) is the person who works under immediate direction of an investigator who is conducting a trial at a trial site; mainly hospital, private clinics or any institute. CRCs are considered as the vital part of the clinical research process because they are involved in the data generation process which on a later stage is evaluated for safety and efficacy of the product being investigated. As they have basic understanding of the terms and codes used by a physician, pharmacists as CRCs can generate data and it is later transcribed in the case report form.
A Clinical Research Associate (CRA) is the person who monitors the activities conducted by CRC and investigator and checks its compliance with the written set of guidelines which are Protocol, SOP, GCPs and other regulatory requirements. While a CRC helps in data generation, a CRA is the person who checks this data for its credibility to be evaluated on regular basis. A CRA needs managerial capabilities, should be well-versed with the research needs, understand the trial related activities, and plays a dynamic role in developing interpersonal relationships between a site CRC, investigator and other members of the work area.
Project manager/ Research Officers
With the experience and knowledge in clinical research, pharmacy graduates can attain a managerial level within the organization as Project Managers, to look after all the trial related activities on regular intervals on the basis of the report provided to them by these clinical research associates. In addition, project managers also help in selecting the investigator in conjunction with the CRA, collect and analyze trial data, reports adverse events to regulatory bodies or sponsors, write and publish trial study report. They also ensure that all trial related activities are completed within the designated timeframe hence reaching milestones that have been set.
Some of the pharmacists may become Research officers who help in writing the trial protocol for the pharmaceutical companies.
In addition, a number of pharmacists work as consultants for biotechnology or small pharmaceutical companies that have a promising compound and are trying to design the first clinical protocol testing the compound's safety in human subjects. As these companies need to think through questions like 'What is the appropriate dose? What is the toxicology profile?', pharmacists provide the right answers because of their knowledge and experience.
Auditors
An experienced CRA with a pharmacy background can choose his/her career as an auditor. An auditor is someone who monitors all the activities of the CRA and trial related documents to ensure that compliance of in the trial is maintained. An Auditor also helps by analyzing errors and in rectifying them.
Drug Safety Specialist
Collecting all the data related to the safety of the drug, such as adverse events, serious adverse events, unexpected drug reactions and compiling them to evaluate the safety profile of the investigational product is a job that can only be performed by a medical candidate or a person with knowledge in pharmacology. Drug Safety Specialists typically scrutinize reports obtained from all the sources (Sites) for their validity, whether or not they are related to the investigational product, outcome of that event and many more.
Clinical Data Management (CDM)
Clinical Data management has now come up with new dimension in clinical research for most of the graduates regardless of their majors. One can also explore his career in CDM at various positions like Data Entry Associate, Data base designer, programmer and many more.
Even in Contract Research Organizations (CROs), there are separate pharmacies to store and dispense investigational drugs that are to be used at trial sites. A pharmacist with knowledge of clinical research has to have understanding of the research activities and the need. Storage of investigational product is essential to the protocol and storage instructions. Maintenance of dispensing logs and accountability of test product can only be done by a pharmacist.
Pharmacists with advanced training may also collaborate with other providers to focus on direct patient care activities. These activities may include policy development or clinical research rather than reviewing and approving prescription orders.
It is thus clear that clinical research offers tremendous opportunities and possibilities for pharmacy graduates. The key for anyone looking to enter into clinical research is to find the right strategic partner to undergo the training, seek internships/projects in clinical research to determine the fit better and network within the industry.
Dr. Sumit has extensive experience in training and research and development in clinical research. He currently manages clinical research operations at Clinical Research Academy of America (CRAA) a leading provider of training and internships in clinical research. For more information, please visit www.clinacademy.com
26 December, 2010
24 December, 2010
GPAT-2011
INFORMATION ABOUT GPAT-2011 EXAMINATION
Graduate Pharmacy Aptitude Test (GPAT-2011) is an All India examination conducted by The M. S. University of Baroda, Vadodara on behalf of All India Council for Technical Education, New Delhi. The REGISTRATION only will be ONLINE (not the Examination) for GPAT-2011 Examination.
GPAT 2010 being organised by M.S. University of Baroda
Therefore, in order to facilitate admission of Pharmacy graduates in M.Pharma as also to award fellowships/scholarships to Pharmacy graduates, AICTE has decided to organize to conduct an examination in the name of Graduate Pharmacy Aptitude Test (GPAT) with effect from academic year 2010-11. Accordingly, a National Monitoring Committee (NMC) was constituted for monitoring the issues pertaining to the policy as well as conduct of GPAT.
NMC, constituted by AICTE has recommended for conduct of 1st GPAT i.e. GPAT-2010 by the M.S. university of Baroda, Vadodara-390002, which has agreed to conduct the examination on May 02, 2010 throughout the country.
Candidates willing to appear in GPAT-2010 may obtain application form along with information brochure from either the office of coordinator GPAT-2010, the M.S. university of Baroda, Vadodara-390002 or from the designated branches of Bank of Baroda, whose information may be obtained from the website of GPAT-2010 at URL http://www.gpat.in, http://www.msubaroda.ac.in
ELIGIBILITY FOR GPAT 2010
Persons holding Bachelor’s degree in Pharmacy (4 years after 10+2) or appearing in the Final year examination of B. Pharmacy (4 years after 10+2) in the year 2010 only are eligible for appearing for GPAT-2010 examination.
GPAT IMPORTANT DATES
The important dates for GPAT-2010 are as follows
Issuing of GPAT application forms and information brochures at :
- Designated branches of Bank of Baroda in various cities or
- By post only from The M.S. University of Baroda, Vadodara 25th January, 2010
Last date for issue of Application Form at :
- Bank Counters (during the Bank timings) 22nd February, 2010
- The M.S. University of Baroda, Vadodara (11:00 am to 05:00 pm) 1st March, 2010
Last date for receipt of completed OMR Application Form along with Pay-in sleep
at GPAT Offfice, The M.S.University of Baroda, Vadodara (upto 05:00 pm) 12th March, 2010
Date of GAPT 2010 Examination (2:00 - 5:00 pm) 2nd May 2010
Announcement of the result of GPAT 2010 24th May 2010
GPAT-2010 examination would be conducted along with JAM-2010 examination on 2nd May 2010 at different centers (to be notified) through out India.
HOW TO APPLY
Candidates should follow the following steps for applying for GPAT-2010 examination :
Step1 : Procurement of Application Form
Candidate can obtain a packet containing :
- Application Form
- Information Brochure
- Acknowledgment Card
- Envelope
from : 1 . Designated Branches of Bank of Baroda
2. GPAT Office by sending a request letter along with a Demand Draft for appropriate amount.
Demand Draft for Application :
The candidates who wish to obtain the Application Form and Information Brochure by post or personally from GPAT office counter should obtain a demand draft (in favor of “GPAT”) for Rs 1000/- (Rs. 500/- for SC/ST/PD) payable at Bank of Baroda, Vadodara.
Step 2 : Filling in the Application Form
Candidates must follow the instructions provided in GPAT 2010 Brochure.
Step 3 : Submission of Application forms
Duly filled-in Application Form with appropriate enclosures must be sent by :
- Registered or Speed post to :
The Co-ordinator, GPAT 2010
The M.S.University of Baroda,
Shri G.H.Patel Pharmacy Building,
Opp. University Main Office,
Donors’ Plaza,Fatehganj,
Vadodara-390 002
on or before Friday, 12th March 2010, 17.00 hrs. - May also be submitted in person at the GPAT Office counter as per the above given timings.
GPAT Exam Structure
The GPAT-2010 examination will consist of a single paper of 3 hours duration containing 100 questions carrying a maximum of 100 marks. The question paper will consist of only multiple choice objective-type questions. Each question will have four choices for the answer. The candidates will have to mark the correct choice on an Optical Response Sheet (ORS) by darkening the appropriate bubble against each question. There will be negative marking for each wrong answer that is 1/3 (one-third) mark will be deducted.
GPAT Examination: Examination will be similar to that of GATE 2009 Examination, where the candidate will mark the correct answer out of four options in an Optical Response Sheet (ORS) by darkening the appropriate bubble.
GPAT SYLLABUS
Syllabus for GPAT 2010 Examination
GPAT Result
a) GPAT 2010 result will be announced on 24th May 2010, 17: 00 hrs at GPAT office. The result will also be available
on the website, as listed in Section 1.6.
b) GPAT 2010 score is valid for ONE YEAR from the date of announcement of the result.
c) The machine-gradable Optical Response Sheets (ORS) are graded and scrutinized with extreme care. There is no provision for regrading or retotalling. No photocopies of the machine-gradable Optical Response Sheets (ORS) will be made available. No correspondence in this regard will be entertained.
All the enquiries regarding GPAT-2011 examination can be obtained from the GPAT Office as given below
The Co-ordinator, GPAT 2011
The M.S.University of Baroda,
Shri. G.H. Patel Pharmacy Building,
Opp: University Main Office,
Donors’ Plaza, Fatehganj,
Vadodara - 390 002
Ph (O) : (0265) 2750821
FAX : (0265) 2750819
Mobile : 09408151958
E-mail : gpat2011@yahoo.com, coordinatorgpat@gmail.com
Website : www.msubaroda.ac.in
Website : www.gpat.in
21 December, 2010
Clinical Research-A new age career
Guest publisher:
Jain Joseph,Programme Co-ordinator,
Institute Of Clinical Research Management (ICRM),
Kochi.
Phone :0484-4014555 / 8129044555
Visit Us at http://www.icrmindia.com
Clinical Research- A new age career
The tremendous increase in medical technology and information in the last decade has resulted in an explosion of potential new drugs, devices and biologics that must be tested before being released for use by the public. The profession is constantly challenged to improve and streamline the clinical research programs in order to shorten the development timelines and control the cost for new product development. With the Govt of India becoming a signatory to the TRIPS Agreement and the new Patent Laws in force in India w.e.f. January 2005, it has became mandatory for all Pharma / biotech companies to undertake clinical trials prior to manufacture or market of a new drug in India.
Unlimited employment opportunities are foreseen for well-trained clinical research professionals specifically into multinational Pharmaceutical companies which is estimated at 50,000 in India and 2,50,000 globally according to leading consulting firm, McKinsey. At present more than 100 contract research organizations have set up operations in India. It presents tremendous high paying employment opportunities in India and abroad.
Clinical research professionals can hold a multitude of positions in Pharmaceutical industry, at the investigational site, or in the clinical research service profession either at a contract research organization (CRO) or a site management organization (SMO). Job titles may include, but are not restricted to, clinical research associate, clinical research scientist, clinical research coordinator, medical writer, clinical trial auditor, clinical trial monitor, product safety specialist, clinical research trainer, etc. Industry (sponsor) and service professions (CRO, SMO) usually provide technical and managerial career paths and ample growth opportunities.
Institute of Clinical Research Management (ICRM) is an internationally recognized Clinical Research Management training organization having operations in Bangkok and India. ICRM was founded with a vision to create a competent resource pool of professionals for the Clinical Research Industry.
ICRM has emerged as the epicenter of Clinical Research education within a very short span of time providing the best of infrastructural facilities to its scholars. ICRM provides training at a fully air conditioned campuses located in Bangalore, Cochin, Calicut, Perinthalmanna and Thalassery. Our campus is well appointed with excellent class rooms, library and infrastructure which have exceptional facilities for organizing Group Discussion rooms, Interview Rooms and Presentation Halls. Campus is well connected with 24/7 internet facility which serves as a great resource for e-learning. We also provide residential accommodation for some of our scholars.
ICRM has created a unique training program to accommodate both industry specific knowledge and skills and practical clinical trial experience through extensive research and collaboration with Sponsors, CROs, and SMOs. Apart from the technical knowledge, organizations are keen on selecting those who are good in communication and stand out
as compared to others. ICRM have developed this program which fills the gap and enforces the youth to equip with much required basic soft skills and embedded an Employability Skills Enhancement Program in the core modules of Clinical Research Management
As part of the program, all scholars will complete an internship practicum in clinical studies and use this experience to write a detailed Internship Practicum Report. The internship may take place either on-campus or at approved sites across the country.
Our scholars participate in our current Clinical Research Management projects to get extensive practical, work related experience. This experience is critical to securing a career position in this industry.
ICRM is conducting symposiums across India to create anawareness about Clinical Research which will discuss the various opportunities and challenges in the field and will aim to develop a resource pool for Clinical Research professionals in India. This is a valuable opportunity for graduates/post graduates and professionals in life science, medicine, pharmacy and nursing to know more about the industry of Clinical Research and related specializations and enhance their employability prospects in these areas. For further details, please visit www.icrmindia.com, e-mail to info@icrmindia.com or call 8129 0 44555
Subscribe to:
Posts (Atom)
