Some common topics that are regularly discussed and covered during internal training at Bioequivalence Study Center!

Introduction to bioequivalence​

What is bioequivalence, and why is it important in drug development?

Regulatory requirements

Overview of the regulatory requirements for bioequivalence studies, including FDA and EMA guidelines.

Study design

Explanation of different study designs for bioequivalence studies, including parallel group, crossover, and replicate design.

Statistical analysis

Explanation of the statistical methods used in bioequivalence studies, including the 90% confidence interval and the two one-sided tests (TOST) approach.

Pharmacokinetics

Overview of pharmacokinetic parameters and how they relate to bioequivalence.

Challenges in bioequivalence

Discussion of the challenges that arise in bioequivalence studies, such as inter-subject variability and formulation differences.

Bioequivalence of complex drugs

Discussion of bioequivalence studies for complex drugs such as generics, biosimilars, and modified-release formulations.

Future of bioequivalence

Discussion of emerging trends in bioequivalence, including the use of modeling and simulation techniques and the impact of personalized medicine.