C-31


| Title | Bioequivalence Studies: Practical Insights from a Leading Contract Research Organization in Indonesia |
|---|---|
| Date | 2026.08.27 (11:00 - 11:30) | Hall C Seminar room |
| Organization | PT BIOMETRIK RISET INDONESIA |
| Speaker | Andi Darmawan, Head of Technical Operation |
[Brief Introduction of Seminar]
This presentation will provide an overview of the current landscape of bioequivalence (BE) studies in Indonesia, including the role of BE studies in supporting generic drug development and ensuring therapeutic equivalence in accordance with Indonesian regulatory requirements. The session will also discuss the practical implementation of BE studies by Contract Research Organizations (CROs), including clinical study conduct, bioanalytical processes, quality management systems, and the development of facilities and capabilities in Indonesia, such as clinical research sites, bioanalytical laboratories, and LC–MS/MS technologies to support end-to-end bioequivalence studies.
[Brief Introduction of Speaker]
Mr. Andi Darmawan serves as Head of Technical Operation at PT Biometrik Riset Indonesia, a Contract Research Organization (CRO) specializing in Bioavailability and Bioequivalence (BA/BE) studies. With more than 17 years of experience in the pharmaceutical and bioanalytical field, he has been actively involved in the technical and operational aspects of bioequivalence studies, including study strategy, bioanalytical processes, and collaboration with pharmaceutical companies. He regularly engages in scientific discussions to support effective study design, address technical challenges, and enhance the success of BE studies. His expertise combines scientific knowledge with practical industry experience, supporting partnerships with both local and international pharmaceutical companies.