Скачать или смотреть Part-1। Pharmaceutical regulatory science 8th sem important questions। Short & long Questions।

Part-1। Pharmaceutical regulatory science 8th sem important questions। Short & long Questions।

pharmaceutical regulatory science 8th sem important questionspharmaceutical regulatory science 8th semPharmaceutical regulatory scienceRegulatory scienceCosmetic ScienceBiostatistics and research methodologySocial and Preventive PharmacyPharmacovigilanceB Pharm 8th semester important questionsShahruddin KhanB PharmD Pharm8th semester

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Hey! My name is Shahruddin Khan
Today In this video I provide Pharmaceutical regulatory science B Pharm 8th semester important questions Short & long questions with solution PDF.

Check other subjects Important questions of B Pharm 8th semester 👇
   • B Pharm 8th semester important questions

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Unit-I
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-II
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-III
Registration of Indian drug product in overseas marketProcedure 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-IV
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-V
Regulatory Concepts
Basic terminology, guidance, guidelines, regulations, Laws and Acts, Orange book, Federal Register, Code of Federal Regulatory, Purple book.

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