Professional Development Meeting : 09-22-2015
Topic: Building Quality in to Generic Drug Development, a Chemistry Perspective
Today about 75% - 80% of medical prescriptions are filled with generic drugs, primarily for their affordability. That said, it is well recognized that the affordability at the cost of quality is not an option. It is extremely important that the safety, efficacy, and quality of the generic drugs are as good as or better than that of the brand product. With this objective, today FDA requirements for product approval and quality standards have become even more stringent for generic drugs. The generic industry, FDA, and other world regulatory agencies have been working hand in hand in this effort to continuously improve upon the quality standards for generic drugs. This presentation illustrates how quality is built into the process starting from development to commercial manufacturing and beyond. Specifically, drug product design, control strategy for raw materials, formulation development (uniformity, potency, stability, drug release, physical attributes, bio-equivalency etc.) will be discussed in this presentation from a chemistry perspective.
The analytical laboratory activities and evaluations play a critical role in design of a successful drug product. Many routine and non-routine studies that are performed in the laboratories contribute towards the design, manufacture, approval, and commercial production of drug products. Highlights from some of those activities (brand product characterization, selection and characterization of raw material, formulation design support, analytical method development/ validation, bio-relevant dissolution method design, drug product stability evaluation etc.) and their relevance will be also be discussed.
Speaker:
Dr. Debashis Das has a Ph.D in Chemistry (Analytical Chemistry) from North Illinois University,DeKalb, IL
Dr Das served with Endo Pharmaceuticals as Research Scientist, Sr. Research Scientist, and Associate Director, between 2001 and 2013.
Dr Das is currently an Associate Director, Analytical Services at Par Pharmaceuticals and serving the USP Committee of Experts (chemistry and medicine)
The analytical laboratory activities and evaluations play a critical role in design of a successful drug product. Many routine and non-routine studies that are performed in the laboratories contribute towards the design, manufacture, approval, and commercial production of drug products. Highlights from some of those activities (brand product characterization, selection and characterization of raw material, formulation design support, analytical method development/ validation, bio-relevant dissolution method design, drug product stability evaluation etc.) and their relevance will be also be discussed.
Speaker:
Dr. Debashis Das has a Ph.D in Chemistry (Analytical Chemistry) from North Illinois University,DeKalb, IL
Dr Das served with Endo Pharmaceuticals as Research Scientist, Sr. Research Scientist, and Associate Director, between 2001 and 2013.
Dr Das is currently an Associate Director, Analytical Services at Par Pharmaceuticals and serving the USP Committee of Experts (chemistry and medicine)
