Regulatory Affairs in the Pharmaceutical Industry (Paperback)

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 industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more.

General

Imprint:	Academic Press Inc
Country of origin:	United States
Release date:	November 2021
First published:	2022
Editors:	Javed, Ali • Sanjula Baboota
Dimensions:	229 x 152mm (L x W)
Format:	Paperback
Pages:	286
ISBN-13:	978-0-12-822211-9
Categories:	Books > Medicine > Nursing & ancillary services > Pharmacy / dispensing Books > Business & Economics > Business & management > Management of specific areas > Production & quality control management Books > Business & Economics > Industry & industrial studies > Manufacturing industries > Pharmaceutical industries Books > Medicine > Other branches of medicine > Pharmacology > General Promotions
LSN:	0-12-822211-5
Barcode:	9780128222119

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