Design Considerations of Generic Dermatological Products
Lakshmi Raghavan, Ph.D. (Solaris Pharma Corporation)
The Food and Drug Administration’s (FDA) approach to approving any generic drug product is based on the Abbreviated New Drug Application (ANDA) providing enough scientific justification to prove it is bioequivalent to the approved Reference Product. For topically administered drugs, the standard approach has been to conduct a clinical end-point study with a pharmaceutically equivalent product and prove therapeutic equivalence with the Reference Product. The pharmaceutical equivalence is established through demonstration of qualitative (Q1) and quantitative (Q2) sameness as well as establishing microstructural arrangement of matter sameness (Q3). Systematic science and risk-based approaches using Quality by Design (QbD) principles are utilized to identify the critical quality attributes (CQA), critical material attributes (CMA) and critical process parameters (CPP) and guide control strategies in developing a quality generic dermatological product. Demonstrating bioequivalence of a pharmaceutically equivalent product through clinical end point studies is extremely complex and expensive due to the lack of sensitivity in detecting differences between the test and the reference product. In vitro Release (IVRT) and skin permeation tests (IVPT) can be used as surrogate tool to predict in vivo performance in human clinical end-point studies. This talk will address some of the design considerations that will be critical in developing a bioequivalent
generic topical product.
Date and Location
Thurs Jan 17th, 2019
Registration & social hour: 5:30 PM
Hanover Marriott1401 Rt 10 E, Whippany, NJ 07981
About the speaker
Dr. Raghavan is a successful, serial entrepreneur with more than 25 years of technical and business development expertise. Lakshmi Raghavan, PhD is currently the Founder and President of Solaris Pharma Corporation, leading its Research & Development, Business Development and overall corporate strategy. Prior to Solaris Pharma Corporation, Dr. Raghavan founded DermPathe Pharmaceuticals in 2010, a contract research organization providing contract research & development services in product development and pre-clinical services.
Dr Raghavan is the Chairman of the In vitro Committee that is part of the Q3 Microstructure Steering Committee. He is also the Community Leader of the AAPS Topical & Transdermal Group. Dr Raghavan was awarded the American Association of Indian Pharmaceutical Scientists’ ‘Distinguished Scientist’ award for his contributions in promoting pharmaceutical science.
Dr Raghavan holds a Bachelor of Science and Master of Science in Physics from the University of Madras, Chennai, India and a Doctor of Philosophy degree in Physics from Indian Institute of Technology, Chennai, India. He has more than 40 research publications and several book chapters.
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