소장자료

Medical product regulatory affairs : pharmaceuticals, diagnostics, medical devices

  • Tobi, John J. , Walsh, Gary
  • Wiley-Blackwell
  • 2008
Medical product regulatory affairs : pharmaceuticals, diagnostics, medical devices

소장사항

소장정보
번호 소장처 청구기호 도서상태 반납예정일 신청/예약
1 연세의학도서관/3층 구관/07서가 2열 344.0416 T629m 대출가능 -

목차

1. The Aims and Structure of Regulations
2. Regulatory Strategy
3. Drug Discovery and Development
4. Non-Clinical Studies
5. Clinical Trials
6. Marketing Authorisation
7. Authorisation of Veterinary Medicines
8. Variations to the Drug Authorisation Process
9. Medical Devices
10. Authorisation of Medical Devices
11. Good Manufacturing Practice (GMP)
12. Oversight and Vigilance