Pharmaceutical Regulatory Science PDF Notes | B Pharmacy 8th Semester Noteskarts
Syllabus
Unit: 1
- New Drug Discovery and development
Stages of drug discovery, Drug development process, pre-clinical studies, non-clinical activities,
clinical studies, Innovator and generics, Concept of generics, Generic drug product
development.
Unit: 2
- Regulatory Approval Process
Approval processes and timelines involved in Investigational New Drug (IND), New Drug
Application (NDA), Abbreviated New Drug Application (ANDA). Changes to an approved
NDA / ANDA. - Regulatory authorities and agencies
Overview of regulatory authorities of India, United States, European Union, Australia, Japan,
Canada (Organization structure and types of applications).
Unit: 3
- Registration of Indian drug product in overseas market
Procedure for export of pharmaceutical products, Technical documentation, Drug Master Files
(DMF), Common Technical Document (CTD), electronic Common Technical Document
(eCTD), ASEAN Common Technical Document (ACTD)research.
Unit: 4
- Clinical trials
Developing clinical trial protocols, Institutional Review Board / Independent Ethics committee –
formation and working procedures, Informed consent process and procedures, GCP obligations
of Investigators, sponsors & Monitors, Managing and Monitoring clinical trials,
Pharmacovigilance – safety monitoring in clinical trials.
Unit: 5
- Regulatory Concepts
Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal Register, Code of Federal Regulatory, Purple book.