Regulatory Affairs in the Pharmaceutical Industry
portes grátis
Regulatory Affairs in the Pharmaceutical Industry
Ali, Javed; Baboota, Sanjula
Elsevier Science Publishing Co Inc
11/2021
286
Mole
Inglês
9780128222119
15 a 20 dias
770
Descrição não disponível.
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
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
ANDA; API; Active pharmaceutical ingredient; Approval process; Australia; BCS classification; Bioavailability; Bioequivalence; Biologics; Biowaiver; CMC; Clinical trial; Clinical trial regulation; Combination products; Dissolution studies; Drug development; Drug discovery; EU; Efficacy; FDA; Good clinical practice; Guidelines; IB; ICH; IMPD; IND; India; Investigator's Brochure; Japan; Marketing; Medical devices; NDA; Nanopharmaceuticals; Nonregulated market; Novel drug delivery systems; Pharmaceutical quality guidelines; Pharmaceuticals; Pharmacovigilance; Quality; ROW; Registration; Regulations; Regulatory requirement; Regulatory requirements; Regulatory submissions; Safety; Specifications; Stability; Stability testing; United Kingdom; United States
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
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
ANDA; API; Active pharmaceutical ingredient; Approval process; Australia; BCS classification; Bioavailability; Bioequivalence; Biologics; Biowaiver; CMC; Clinical trial; Clinical trial regulation; Combination products; Dissolution studies; Drug development; Drug discovery; EU; Efficacy; FDA; Good clinical practice; Guidelines; IB; ICH; IMPD; IND; India; Investigator's Brochure; Japan; Marketing; Medical devices; NDA; Nanopharmaceuticals; Nonregulated market; Novel drug delivery systems; Pharmaceutical quality guidelines; Pharmaceuticals; Pharmacovigilance; Quality; ROW; Registration; Regulations; Regulatory requirement; Regulatory requirements; Regulatory submissions; Safety; Specifications; Stability; Stability testing; United Kingdom; United States
