Design Considerations in Development of Generic Dermatologicals
Regional Meeting May 10, 2018
Guest Speaker: Dr. Lakshmi Raghavan
Dr.Raghavan is a successful 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 topical 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 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.
Mark your calendars! We invite you to our first 2018 regional meeting on Thursday, May 10th. This meeting event features a social hour followed by a presentation of interest to the membership concerning new developments in the industry followed by dinner.
Topic: Design Considerations in Development of Generic Dermatologicals
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.
Venue: Crown of India Restaurant (609) 275-5707
Address: 660 Plainsboro Rd, Plainsboro Township, NJ 08536
Time: Social Hour 05:30 - 6:15PM
Presentation by Guest speaker 6:15 – 7:00 PM
Dinner 7:00 – 8:30 PM
Registration is now open, follow www.aaips.org for more details
Event sponsored by the Crown of India Restaurant