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| BOOK REVIEW |
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| Year : 2013 | Volume
: 45
| Issue : 6 | Page : 647 |
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Regulatory requirements for drug development and clinical research
Ram K Dikshit
Department of Pharmacology, B J Medical College, Ahmedabad - 380 016, Gujarat, India
| Date of Web Publication | 14-Nov-2013 |
Correspondence Address:
Ram K Dikshit
Department of Pharmacology, B J Medical College, Ahmedabad - 380 016, Gujarat
India
 Source of Support: None, Conflict of Interest: None  | Check |
How to cite this article:
Dikshit RK. Regulatory requirements for drug development and clinical research. Indian J Pharmacol 2013;45:647 |
 Nilima Kshirsagar, Tejashree N Kulkarni, Anish Desai, Jatin Y Shah
Publishers: Indian Council of Medical Research,
New Delhi, First edition, 2013,
pp. 376,
Price: Rs. 700
''Clinical Research'' is an integral part of the new drug development process. It has come to India in a big way for a number of reasons. Since this activity involves the experimentation on healthy human volunteers or patients, it needs to be regulated as stringently as possible. Accordingly, the national agencies have come up with a number of provisions that are meant to be followed mandatorily. This is a welcome step. However, it is generally felt that most of the investigators are usually unaware of many statutory requirements and working details. This book is a compilation of all that must be known to an investigator (or others involved in clinical research) both from the scientific as well as a regulatory view point.
Although the book has been published by the Indian Council of Medical Research (ICMR), it is a multi-authored treatise. To its credit, each of the contributors seems to be connected directly with some area of clinical research and, therefore, a lot of narration is based upon the personal experience. The book is divided in four sections covering a large number of topics ranging from the regulatory aspects of animal experiments to phase IV studies and pharmacovigilance. Several sparingly discussed topics are also included e.g., clinical trials in pregnant and nursing women, making a new drug application, traditional medicine and clinical evaluation/trials of vaccines, cosmetics etc. The book is reasonably comprehensive, yet, conveniently precise and compact. It is moderately priced and has easy to read, large typefaces. The book appears to be must for those who are already in clinical research or likely to be there in future. However, as the regulations are still being evolved, one would need to be updated regularly about them.
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