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.
1. Chapter 1 : Drug regulatory affairs: an introduction - p. Page xiv 2. Chapter 2 : Regulatory requirement for the approval of novel, nanotechnology-based biological products - p. Page 29 3. Chapter 3 : International Council for Harmonisation (ICH) guidelines - p. Page 45 4. Chapter 4 : Regulatory affairs for chemistry, manufacturing, and controls - p. Page 72 5. Chapter 5 : Global submissions for drug approvals - p. Page 86 6. Chapter 6 : Regulatory requirements of regulated market - p. Page 109 7. Chapter 7 : Pharmaceutical regulatory requirements of nonregulated markets - p. Page 158 8. Chapter 8 : Drug product performance and scale-up process approval changes - p. Page 213 9. Chapter 9 : Regulatory affairs in clinical trials - p. Page 236 10. Index - p. Page 259
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.
1. Chapter 1 : Drug regulatory affairs: an introduction - p. Page xiv 2. Chapter 2 : Regulatory requirement for the approval of novel, nanotechnology-based biological products - p. Page 29 3. Chapter 3 : International Council for Harmonisation (ICH) guidelines - p. Page 45 4. Chapter 4 : Regulatory affairs for chemistry, manufacturing, and controls - p. Page 72 5. Chapter 5 : Global submissions for drug approvals - p. Page 86 6. Chapter 6 : Regulatory requirements of regulated market - p. Page 109 7. Chapter 7 : Pharmaceutical regulatory requirements of nonregulated markets - p. Page 158 8. Chapter 8 : Drug product performance and scale-up process approval changes - p. Page 213 9. Chapter 9 : Regulatory affairs in clinical trials - p. Page 236 10. Index - p. Page 259
