Regulatory Affairs in the Pharmaceutical Industry
Editat de Javed Ali, Sanjula Babootaen Limba Engleză Paperback – 14 noi 2021
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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Specificații
ISBN-13: 9780128222119
ISBN-10: 0128222115
Pagini: 286
Dimensiuni: 216 x 276 mm
Greutate: 0.67 kg
Editura: ELSEVIER SCIENCE
ISBN-10: 0128222115
Pagini: 286
Dimensiuni: 216 x 276 mm
Greutate: 0.67 kg
Editura: ELSEVIER SCIENCE
Cuprins
1. Documentation in Pharmaceutical industry
2. Generic drugs product development
3. CFR (CODE OF FEDERAL REGULATION)
4. ANDA regulatory approval process
5. NDA approval process
6. Post marketing surveillance
7. US registration for foreign drugs
8. Regulation for combination products and medical devices
9. CTD and ECTD formats
10. Regulatory Guidelines of ICH-Q, S E, M
11. Regulatory requirements of EU, MHRA, TGA and ROW countries
12. Global submission of IND, NDA, ANDA
13. Investigation of medicinal products dossier
14. Regulatory Affairs in Clinical trials
15. Pharmacovigilance safety monitoring
2. Generic drugs product development
3. CFR (CODE OF FEDERAL REGULATION)
4. ANDA regulatory approval process
5. NDA approval process
6. Post marketing surveillance
7. US registration for foreign drugs
8. Regulation for combination products and medical devices
9. CTD and ECTD formats
10. Regulatory Guidelines of ICH-Q, S E, M
11. Regulatory requirements of EU, MHRA, TGA and ROW countries
12. Global submission of IND, NDA, ANDA
13. Investigation of medicinal products dossier
14. Regulatory Affairs in Clinical trials
15. Pharmacovigilance safety monitoring