--- Content provided by FirstRanker.com ---Answer any five questions
All questions carry equal marks
- - -
1. Describe the following approaches for the drug discovery process:
b) Dosage form. [7+7]
2. Describe the importance of the following in Drug Development process:
a) Pharmacological
3.a) What are the different phases of clinical trials. Explain in detail.
b) Write about CDSCO guidelines. [7+7]
a) Methods of post marketing surveillance
b) Challenges in the implementation of guidelines. [7+7]
5. Describe the following:
b) Composition, responsibilities and procedures of IEC [7+7]
6. Describe the responsibilities of the following personnel as per ICH GCP:
a) Sponsor
7.a) Describe the protocol involved in the Abbreviated NDA submission.
b) Write about designing of clinical study documents. [7+7]
b) Write about the Safety monitoring in clinical trials. [7+7]
---ooOoo---
FirstRanker.com - FirstRanker's Choice
All questions carry equal marks
- - -
1. Describe the following approaches for the drug discovery process:
--- Content provided by FirstRanker.com ---
a) Drug characterizationb) Dosage form. [7+7]
2. Describe the importance of the following in Drug Development process:
a) Pharmacological
--- Content provided by FirstRanker.com ---
b) IND application. [7+7]3.a) What are the different phases of clinical trials. Explain in detail.
b) Write about CDSCO guidelines. [7+7]
--- Content provided by FirstRanker.com ---
4. Write about the following:a) Methods of post marketing surveillance
b) Challenges in the implementation of guidelines. [7+7]
5. Describe the following:
--- Content provided by FirstRanker.com ---
a) Overview of regulatory environment in Europe.b) Composition, responsibilities and procedures of IEC [7+7]
6. Describe the responsibilities of the following personnel as per ICH GCP:
a) Sponsor
--- Content provided by FirstRanker.com ---
b) Investigators [7+7]7.a) Describe the protocol involved in the Abbreviated NDA submission.
b) Write about designing of clinical study documents. [7+7]
--- Content provided by FirstRanker.com ---
8.a) Discuss the overview on Ethical guidelines in Clinical Research.b) Write about the Safety monitoring in clinical trials. [7+7]
---ooOoo---
--- Content provided by FirstRanker.com ---
FirstRanker.com - FirstRanker's Choice