Product Description
Regulatory Affairs in the Pharmaceutical Industry
A comprehensive reference on regulatory affairs in the global Pharmaceutical Industry
Javed Ali (Edited by), Sanjula Baboota (Edited by)
9780128222119, Elsevier Science
Paperback / softback, published 15 November 2021
286 pages
27.6 x 21.6 x 1.9 cm, 0.77 kg
Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application).
Chapters cover documentation in the pharmaceutical]
Regulatory Affairs in the Pharmaceutical Industry Ali Baboota Paperback
Regulatory Affairs in the Pharmaceutical Industry
A comprehensive reference on regulatory affairs in the global Pharmaceutical Industry
Javed Ali (Edited by), Sanjula Baboota (Edited by)
9780128222119, Elsevier Science
Paperback / softback, published 15 November 2021
286 pages
27.6 x 21.6 x 1.9 cm, 0.77 kg
Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application).
Chapters cover documentation in the pharmaceutical]
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