Regulatory Affairs in the Pharmaceutical Industry 1st Edition by Javed Ali 9780128222232 0128222239
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Regulatory Affairs in the Pharmaceutical Industry 1st Edition Javed Ali – Ebook Instant Download/Delivery ISBN(s): 9780128222119, 0128222115, 9780128222232, 0128222239
Product details:
- ISBN 10: 0128222239
- ISBN 13: 9780128222232
- Author: Javed Ali
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.
Table contents:
Chapter 1. Drug regulatory affairs: an introduction
Chapter 2. Regulatory requirement for the approval of novel, nanotechnology-based biological products
Chapter 3. International Council for Harmonisation (ICH) guidelines
Chapter 4. Regulatory affairs for chemistry, manufacturing, and controls
Chapter 5. Global submissions for drug approvals
Chapter 6. Regulatory requirements of regulated market
Chapter 7. Pharmaceutical regulatory requirements of nonregulated markets
Chapter 8. Drug product performance and scale-up process approval changes
Chapter 9. Regulatory affairs in clinical trials
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