Journal of Bioequivalence & Bioavailability

Dissolution testing for generic drugs: An FDA perspective

2^nd World Congress on Bioavailability & Bioequivalence: Pharmaceutical R & D Summit-2011 and International Conference on Pharmaceutics & Novel Drug Delivery Systems

06-08 June 2011, Las Vegas, USA

Om Anand

Scientific Tracks Abstracts: JBB

Abstract:

I n vitro dissolution testing is an important tool used for development and approval of generic dosage forms. Th e objective of this presentation is to summarize how dissolution testing is used for the approval of safe and eff ective generic drug products in the United States (US). Dissolution testing is routinely used for stability and quality control purposes for both oral and non-oral dosage forms. Th e dissolution method should be developed using an appropriate validated method depending on the dosage form. Th ere are several ways in which dissolution testing plays a pivotal role in regulatory decision-making. It may be used to waive in vivo bioequivalence (BE) study requirements, as BE documentation for Scale Up and Post Approval Changes (SUPAC), and to predict the potential for a modifi ed-release (MR) drug product to dose-dump if co-administered with alcoholic beverages. Th us, in vitro dissolution testing plays a major role in FDA?s eff orts to reduce the regulatory burden and unnecessary human studies in generic drug development without sacrifi cing the quality of the drug products

Biography :

Om Anand, Ph.D., Division of Bioequivalence, OGD, CDER, FDA: Rockville, MD. Dr. Anand is a reviewer and dissolution focal point at Division of Bioequivalence-2, Of fi ce of Generic Drugs, CDER, FDA at Rockville, Maryland. He received his Bachelor in Pharmacy from the University of Delhi, India in 1997, and a Master in Pharmacy in 2000 from the Punjabi University Patiala, Punjab, India. He received his Doctorate in Pharmaceutical Sciences from the University of Tennessee, USA, in 2008. His Ph.D. research involved formulation and development of biodegradable injectable gels loaded with insulin. From 2000 to 2003, he worked in pharmaceutical industry as a formulation scientist and developed wide variety of modi fi ed-release solid oral dosage forms. Research interests have included Pharmacokinetics, Biopharmaceutics and in-vitro dissolution of poorly soluble drugs and in-vitro and in-vivo correlations. He has published several articles and has two patents on his name.