Bioequivalence studies overview

Bioequivalence (BE) study is required to show whether a generic product can be interchangeable with the brand innovator product. The importance of bioequivalence studies is increasing due to the large growth of the production and consumption of the generic products.

Category: Crash Courses
Duration : 165 minutes

Learning objectives

Terminologies, phases of clinical trials, Bio-equivalence study requirements, work-flow, the conduct of study, acceptance criteria, bio-waivers

Eligibility

B.Pharm/M.Pharm/M.Sc/B.Sc/MBA/ PhD/ Working professionals from Pharma/Bio-tech industry [QC/QA/R & D/F & D/ ADL/ RA/ Patents/International business etc] & those aspiring to enhance their regulatory affairs knowledge. Anyone willing to understand this topic can enroll.

Syllabus

  • Section 1: BE overview
    • Bio-equivalence studies 165 minutes

Fees : 2950

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