BP804 ET PHARMACEUTICAL REGULATORY SCIENCE Books : Pharmalite.in

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BP804 ET. PHARMACEUTICAL  REGULATORY SCIENCE Books

All books are given below after syllabus

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 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-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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