Exam Details
| Subject | pharmacological and toxicological screening methods - ii | |
| Paper | ||
| Exam / Course | m. pharmacy (pharmacognosy) | |
| Department | ||
| Organization | G. Pulla Reddy College Of Pharmacy | |
| Position | ||
| Exam Date | February, 2019 | |
| City, State | telangana, hyderabad |
Question Paper
FACULTY OF PHARMACY
M. Pharmacy (Pharmacology) II-Semester (Suppl.) Examination,
February 2019
Subject: Pharmacological and Toxicological Screening Methods II
Time: 3 Hours Max. Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1. Explain the regulatory requirements of ICH for the new drug safety assessment. 15
2. Explain the OECD guidelines for the conduct of acute, sub-acute and chronic toxicity
studies. 15
3. Write short notes on:
Genotoxicity studies 8
Carcinogenicity studies 7
4. Define IND. Elucidate the importance and industry perspectives of IND enabling studies. 15
5. Define safety pharmacology. Describe in detail the Tier1 and Tier2 safety pharmacology
studies. 15
6. What is Toxicokinetics? Discuss its importance and applications in preclinical toxicity
testing of drugs. 15
7. Discuss the study design and importance of reproductive toxicity testing. 15
8. Describe how skin sensitization studies are conducted. 15
M. Pharmacy (Pharmacology) II-Semester (Suppl.) Examination,
February 2019
Subject: Pharmacological and Toxicological Screening Methods II
Time: 3 Hours Max. Marks: 75
Note: Answer any five questions. All questions carry equal marks.
1. Explain the regulatory requirements of ICH for the new drug safety assessment. 15
2. Explain the OECD guidelines for the conduct of acute, sub-acute and chronic toxicity
studies. 15
3. Write short notes on:
Genotoxicity studies 8
Carcinogenicity studies 7
4. Define IND. Elucidate the importance and industry perspectives of IND enabling studies. 15
5. Define safety pharmacology. Describe in detail the Tier1 and Tier2 safety pharmacology
studies. 15
6. What is Toxicokinetics? Discuss its importance and applications in preclinical toxicity
testing of drugs. 15
7. Discuss the study design and importance of reproductive toxicity testing. 15
8. Describe how skin sensitization studies are conducted. 15
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