The book discusses the guidelines, methodology and instrumental techniques under the framework of regulatory affairs for clinical research, which will be of immense help to the students, scholars, scientists and executives of the pharmaceutical industries who will be rendering services to this specific area of pharmacokinetics and pharmacodynamics.
The appendix at the end of the book provides the standard protocols for carrying out bioequivalence study, toxicity study, and clinical trial as formulated by the regulatory authorities of FDA. These protocols are of immense help to the practising executives and scientists. The distinguished contributors have made their best efforts in sharing their experiences and knowledge to accelerate the growth and development of pharmaceutical industries and to drive India to a golden hub of clinical research.
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