Exam Details
Subject | pharmacovigilance | |
Paper | ||
Exam / Course | b.pharm | |
Department | ||
Organization | Gujarat Technological University | |
Position | ||
Exam Date | May, 2017 | |
City, State | gujarat, ahmedabad |
Question Paper
Seat No.: Enrolment No.
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Pharm. SEMESTER-VII • EXAMINATION SUMMER 2017
Subject Code: 2270010 Date: 10/05/2017
Subject Name: Pharmacovigilance
Time: 02:30 PM to 05:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1
Describe pattern and scale of counterfeiting.
06
Describe structure, validity and assessment of ICSRs in pharmacovigilance.
05
Write a note on pharmacovigilance in clinical trial
05
Q.2
Write a note on WHO international drug monitoring programme.
06
Write a note on pharmacovigilance regulation in india.
05
Write a note on Dermatological ADRs.
05
Q.3
Write role of ICSRs in pharmacovigilance
06
What are medication errors? Give types of medication errors with examples.
05
Write methods of detection of medication errors.
05
Q.4
Explain the term: Substandard, Spurious, Falsely labelled, Falsified medicine
06
Describe pharmacogenetic causes of ADRs.
05
Discuss hepatic adverse reactions.
05
Q.5
Explain spontaneous reporting of ADRs with suitable examples.
06
Define SRS. Discuss potential and limitation of SRS.
05
Discuss forms and formats of SRS.
05
Q. 6
Compare and contrast between WHO and Naranjo scale of causality assessment of ADRs.
06
Define signal. Discuss source and scope of signal detection
05
Write mechanism of ADRs with examples.
05
Q.7
Define ADRs. Explain the types of ADRs with suitable examples.
06
Explain current methods of pharmacovigilance.
05
Write role of pharmacist in the management of adverse drug reactions.
05
GUJARAT TECHNOLOGICAL UNIVERSITY
B.Pharm. SEMESTER-VII • EXAMINATION SUMMER 2017
Subject Code: 2270010 Date: 10/05/2017
Subject Name: Pharmacovigilance
Time: 02:30 PM to 05:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1
Describe pattern and scale of counterfeiting.
06
Describe structure, validity and assessment of ICSRs in pharmacovigilance.
05
Write a note on pharmacovigilance in clinical trial
05
Q.2
Write a note on WHO international drug monitoring programme.
06
Write a note on pharmacovigilance regulation in india.
05
Write a note on Dermatological ADRs.
05
Q.3
Write role of ICSRs in pharmacovigilance
06
What are medication errors? Give types of medication errors with examples.
05
Write methods of detection of medication errors.
05
Q.4
Explain the term: Substandard, Spurious, Falsely labelled, Falsified medicine
06
Describe pharmacogenetic causes of ADRs.
05
Discuss hepatic adverse reactions.
05
Q.5
Explain spontaneous reporting of ADRs with suitable examples.
06
Define SRS. Discuss potential and limitation of SRS.
05
Discuss forms and formats of SRS.
05
Q. 6
Compare and contrast between WHO and Naranjo scale of causality assessment of ADRs.
06
Define signal. Discuss source and scope of signal detection
05
Write mechanism of ADRs with examples.
05
Q.7
Define ADRs. Explain the types of ADRs with suitable examples.
06
Explain current methods of pharmacovigilance.
05
Write role of pharmacist in the management of adverse drug reactions.
05
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- agronomy and forestry of medicinal plants
- anatomy physiology & health education -ii
- anatomy, physiology and health education (aphe)
- applied mathematics (biostatistics)
- basic computer applications
- basic concepts of pharmacology and clinical pharmacy practice
- basics of computer applications
- bioavailability & therapeutic drug monitoring
- bioavailability and therapeutic drug monitoring
- biochemistry
- clinical pharmacy ii
- clinical pharmacy-i
- commerce of herbs and phytoconstitutents
- computer applications in drug discovery
- current advances in novel drug delivery systems
- cyber security
- disaster management
- dispensing pharmacy i
- dispensing pharmacy i and drug store management
- dispensing pharmacy ii and pharma industrial management
- dosage form design –i
- dosage form design- i
- dosage form design- ii
- dosage form design-i
- dosage form design-ii
- drug approval process
- environmental studies
- environmental toxicology and green audit
- food analysis
- forensic pharmacy
- forensic pharmacy-i
- genetic engineering and gene therapy
- green chemistry
- health education and community health
- herbal cosmetics
- hospital and community pharmacy
- hospital management and medical tourism
- hospital pharmacy, community pharmacy & forensic pharmacy
- hospital pharmacy, community pharmacy and dispensing pharmacy-ii
- human anatomy physiology
- human anatomy physiology and health education-ii
- human anatomy physiology-ii
- human anatomy, physiology and health education - i
- innovations in conventional drug delivery system
- instrumental and process validation
- intellectual property rights and patents
- medical writing and coding
- medicinal biochemistry
- nutraceuticals
- pathophysiology
- pharmaceutical analysis ii
- pharmaceutical analysis iii
- pharmaceutical analysis iv
- pharmaceutical analysis-i
- pharmaceutical analysis-ii
- pharmaceutical analysis-iv
- pharmaceutical chemistry – ii
- pharmaceutical chemistry – vi (organic chemistry – ii)
- pharmaceutical chemistry –viii (medicinal chemistry - ii)
- pharmaceutical chemistry iii
- pharmaceutical chemistry iv
- pharmaceutical chemistry vii
- pharmaceutical chemistry-i
- pharmaceutical chemistry-i (inorganic chemistry)
- pharmaceutical chemistry-ii (physical chemistry)
- pharmaceutical chemistry-iii (biochemistry – i)
- pharmaceutical chemistry-iv (organic chemistry-i)
- pharmaceutical chemistry-ix (medicinal chemistry-iii)
- pharmaceutical chemistry-v
- pharmaceutical chemistry-v (biochemistry-ii)
- pharmaceutical chemistry-vi (medicinal)
- pharmaceutical chemistry-vii
- pharmaceutical chemistry-viii
- pharmaceutical chemistry-x
- pharmaceutical chemistry-x (medicinal chemistry-iii)
- pharmaceutical engineering
- pharmaceutical engineering-ii
- pharmaceutical inorganic chemistry
- pharmaceutical marketing management
- pharmaceutical microbiology - i
- pharmaceutical microbiology & biotechnology i
- pharmaceutical microbiology &biotechnology- ii
- pharmaceutical microbiology and biotechnology - ii
- pharmaceutical organic chemistry
- pharmaceutical technology - i
- pharmaceutical technology – i
- pharmaceutical technology- ii
- pharmaceutical technology-i
- pharmaceutical technology-ii
- pharmaceutics-i
- pharmaceutics-ii
- pharmaceutivcal chemistry ix
- pharmacognosy iii
- pharmacognosy iv
- pharmacognosy vi
- pharmacognosy vii
- pharmacognosy vii (herbal formulations & complimentary therapies)
- pharmacognosy-i
- pharmacognosy-ii
- pharmacognosy-iii
- pharmacognosy-iv
- pharmacognosy-v
- pharmacognosy-v (plant bio technology)
- pharmacognosy-vi
- pharmacology -iii
- pharmacology & pharmacotherapeutics-ii
- pharmacology and pharmacotherapeutics - i
- pharmacology and pharmacotherapeutics - iii
- pharmacology and pharmacotherapeutics-iv
- pharmacology-i
- pharmacology-ii
- pharmacovigilance
- pharmacy practice
- physical pharmaceutics-ii
- physical pharmacy
- quality by design (qbd) and process analytical technology (pat)
- regulatory aspects of food and neutraceuticals
- remedial mathematics
- unit operation - i
- unit operation - ii