B Pharm Pharmaceutical Regulatory Sciences Unit 2 PDF Notes
B-Pharmers, demystify the drug approval maze in B Pharm Pharmaceutical Regulatory Sciences Unit 2 PDF Notes! Imagine guiding medications from labs to patients, understanding the intricate steps involved. Buckle up as we explore the timelines and processes for Investigational New Drug (IND), allowing initial human testing, and New Drug Application (NDA), seeking full market approval. Feeling curious about generics? We’ll delve into the Abbreviated New Drug Application (ANDA) process for demonstrating bioequivalence. But it’s not just a national game; we’ll explore the regulatory authorities of India, US, EU, and more, understanding their requirements and application types. Remember, knowledge is power; by the end of this unit, you’ll be equipped to navigate the intricate world of drug approvals, contributing to bringing safe and effective medications to the world!
B Pharm Pharmaceutical Regulatory Sciences Unit 2 PDF Notes
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)
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