KIP: Krishna Institute of Pharmacy organized Industry Connect Guest Lecture Series (Session 2)
Name of the activity: Industry Connect Guest Lecture Series
Session: 2
Name of the Speaker: Mr. Makarand Shelake
Name of the topic: Bioavailability/ Bioequivalence and regulatory requirement
Date of activity: 07/08/2025
No. of students Participated: 60
Time: 04:00 to 05:00 pm
An insightful online session on “Bioavailability/Bioequivalence (BA/BE) and Regulatory Requirements “was conducted with the objective of the session aimed to enhance participants’ understanding of the scientific principles, regulatory aspects, and practical conduct of BA/BE studies, which are crucial in the development and approval of pharmaceutical products.
Eminent speaker began by explaining the difference between reference drugs and generic drugs. He highlighted that reference (innovator) drugs are expensive due to the extensive R&D, clinical trials, and regulatory approval processes spanning 12–15 years and costing around USD 1 billion. In contrast, generic drugs are 30–80% cheaper since they bypass the initial discovery and clinical testing phases, focusing instead on demonstrating bioequivalence to the reference drug. Generic drugs can only be marketed after patent expiry of the innovator product. The speaker then discussed the conduct of Bioequivalence studies, emphasizing:
- Use of healthy human volunteers for ethical and scientific reasons.
- Protection of subjects and maintaining confidentiality of their information.
- Designing, conducting, and analysing studies based on sound scientific principles.
- Clearly pre-defined study objectives and careful selection of appropriate volunteers.
- The various phases of BE studies, including the Clinical Phase, Bioanalytical Phase, Pharmacokinetic Phase, and Statistical Phase.
