Regulation of Clinical Trials
Published by KONGPOSH, 2007
ISBN 10: 819062640X (ISBN 13: 9788190626408)
- Hardcover
- New
Seller: Vedams eBooks (P) Ltd, New Delhi, IndiaVedams eBooks (P) Ltd
AbeBooks seller since January 30, 2009
Condition: New
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Item description from seller
Contents 1. Regulation of clinical trials in India an introduction. 2. Revised schedule Y of drugs and cosmetics rules. 3. Rule 122 of Drugs and Cosmetics Act. 4. Application format for undertaking clinical trial in India. 5. Format for fees submission. 6. Conditions for import of drugs for examination test or analysis. 7. Conditions for manufacture of drugs for examination test or analysis. 8. Stocking of drugs. 9. Indian GCP Guidelines. 10. Guidelines for bioavailability and bioequivalence studies. 11. ICH Harmonized Tripartite Guideline Guideline for good clinical practice E6(R1). 12. Data Safety Monitoring Board. 13. Registrations of clinical trials. 14. The Nuremberg Code. 15. The Belmont Report ethical principles and guidelines for the protection of human subjects of research. 16. Clinical research organisations in India. This book on Regulation of Clinical Trials is a valuable compilation of benchmark national and international guidelines and statements relating to clinical research along with original chapters written by the author. The book also deals with various provisions of Drugs and Cosmetics Act and Rules thereunder which lays down conditions and requirements for the conduct of clinical trials in India. Various important topics like Data Safety Monitoring Board and Registrations of Clinical Trials have been incorporated. 350 pp.…
Seller Inventory # 72315
Bibliographic details
- Title
- Regulation of Clinical Trials
- Author
- Rakesh Kumar Rishi
- Publisher
- KONGPOSH
- Publication year
- 2007
- Condition
- New
- Binding
- Hardcover
Vedams eBooks (P) Ltd
New Delhi, India
AbeBooks seller since January 30, 2009
Shipping rates from India to U.S.A.
| Item | 20 to 24 business days | 4 to 7 business days |
|---|---|---|
| First item | £ 15.02 | £ 27.47 |
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