Aliasgar Shahiwala
Dubai Pharmacy College, UAE
Biography
Generic drugs are copies of innovator drugs that have exactly the same dosage, intended use, adverse effects, route of administration, risks, safety, and strength as the original drug. Since, the extensive preclinical and clinical studies were conducted by the innovator; these studies are not required for the generic products. The generic product must demonstrate the bioequivalence to the innovator product. Bioequivalence is also needed in case of post approval changes in pharmaceutical formulations, manufacturing process, batch size, excipients, which is going to be a costly and time consuming affair for a pharmaceutical company. Recent time brought a paradigm shift in the approach of both industry and regulators with respect to biowaiver leading to avoidance of unnecessary exposure of drugs to healthy subjects and huge investment of resources to prove the obvious, specifically, for generic players it is very critical to develop copycat product with very limited resources. In this regard, the concept and application of the in vitro-in vivo correlation (IVIVC) is the major focus in pharmaceutical product development in order to reduce time and efforts. This workshop will focus on step by step procedure to establish Level A correlation using a diclofenac sodium extended release tablet case study using simple Microsoft Excel software. With time permits Level B and C correlations will also be demonstrated.