Regulatory Requirements and Approaches

Bioequivalence regulations have made stricter, yet there is ample scope of improvement in present bioequivalence study designs. Bioavailability and Bioequivalence studies are conducted in healthy human volunteer in study centre. Study centres requires Clinical Pharmacology Unit (CPU) and Bio analytical laboratory. The design and conduct of comparative bioavailability studies are formulated. Investigator(s) should have appropriate expertise, qualifications and competence to undertake a proposed study and is familiar with pharmacokinetic theories underlying bioavailability studies. The design should be based on a reasonable knowledge of the pharmacodynamics and/or the pharmacokinetics of the active substance in question. BA/BE studies are needed by regulations to guarantee remedial proportionality between a pharmaceutically comparable test item and a reference item. BA/BE studies are finished Early and late clinical trial definitions, Formulations utilized as a part of clinical trial and steadiness studies.

  • WHO Approaches
  • FDA Approach and regulations
  • TGA and risk management approach
  • Food-Effect Bioavailability and Fed Bioequivalence Studies
  • European Guidelines

Related Conference of Regulatory Requirements and Approaches

November 09-11, 2017

4th European Biopharma Congress

Vienna, Austria
August 20-22, 2018

9th Asian Biologics and Biosimilars Congress

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