- 286 pages
- English
- ePUB (mobile friendly)
- Available on iOS & Android
eBook - ePub
Regulatory Affairs in the Pharmaceutical Industry
About this book
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.
- Updated reference on drug approval processes in key global markets
- Provides comprehensive coverage of concepts and regulatory affairs
- Presents a concise compilation of the regulatory requirements of different countries
- Introduces the fundamentals of manufacturing controls and their regulatory importance
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Please note we cannot support devices running on iOS 13 and Android 7 or earlier. Learn more about using the app.
Yes, you can access Regulatory Affairs in the Pharmaceutical Industry by Javed Ali,Sanjula Baboota in PDF and/or ePUB format, as well as other popular books in Medicine & Operations. We have over one million books available in our catalogue for you to explore.
Information
Table of contents
- Cover
- Title page
- Table of Contents
- Copyright
- Dedication
- Contents
- List of contributors
- Editor biographies
- Preface
- List of Illustrations
- List of Tables
- 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
- Index
- A