Regulatory affairs/ regulatory requirements for drug approval
Synopsis
Introduction, Regulatory Affairs Historical Overview, Regulatory Authorities, Regulatory Affairs Department Role, and Regulatory Affairs Professionals' Responsibilities. Regulations needed to approve a drug: Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Pharmacology, Drug Metabolism and Toxicology, Non-Clinical Drug Development, Pharmacology, Investigational New Drug (IND) Application, Investigator's Brochure (IB) and New Drug Application (NDA), and Management of Clinical Studies.
Keywords: Drug Approval, Clinical Research, Investigational New Drug (IND), New Drug Application (NDA), Biostatistics
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Volume
Pages
59-97
Published
February 5, 2025
Categories
Copyright (c) 2025 Varda S. Joshi; Anurag R. Panade, Abhishek R. Veer, Ruturaj T. Pawar, Sandip A. Bandgar, Riya R. Patil, Dhanashree R. Davare, Prajakta R. Patil; Sachin S. Mali, Durgacharan A. Bhagwat, Pavan V. Chavan; Pratik P. Kudale
How to Cite
Patil, P. R. ., Mali, S. S. ., Patil, R. R. ., & Davare, D. R. . (2025). Regulatory affairs/ regulatory requirements for drug approval. In V. S. Joshi, S. S. . Mali, D. A. . Bhagwat, & P. V. . Chavan (Eds.), Technology and Quality in Industrial Pharmacy: Theory and Practice in Pharmaceutical Sciences (pp. 59-97). Deep Science Publishing. https://doi.org/10.70593/978-93-49307-31-5_3
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