The Center hosted a thematic seminar for representatives of the pharmaceutical industry on demonstrating bioequivalence under the biowaiver procedure based on the Biopharmaceutics Classification System (BCS).
The training was organized by the Agency for Methodological and Scientific-Practical Work jointly with specialists of the Directorate for Expert Evaluation of Bioavailability and Bioequivalence Materials of the Center.
The focus is on modern approaches to justifying the generic nature of medicinal products in accordance with the requirements of the international guideline ICH M9 and the national guideline ST-N MOZU 42-7.5:2023. The application of the biowaiver tool based on the BCS, at the intersection of science and regulation, makes it possible to bring high-quality, safe, and effective generic products to the market faster.
Training for those present was conducted by the Head of the Directorate for Expert Evaluation of Bioavailability and Bioequivalence Materials of the Center, Candidate of Pharmaceutical Sciences Nadiia Zhukova, and the Head of the Division for Expert Evaluation of Medicinal Product Materials under the Full Dossier Oksana Nahorniak.
Nadiia Zhukova introduced the participants to:
- concept of bioequivalence
- peculiarities of the approach to proving bioequivalence depending on the dosage form
- approaches to selecting and justifying the reference product, sources for searching information
- requirements for conducting the biowaiver procedure based on the BCS and typical errors.
Oksana Nahorniak focused in more detail on the following issues:
- determination of the solubility of the active substance according to the BCS
- preparation of bioavailability materials (absolute bioavailability, mass balance, Caco 2)
- requirements for excipients, for conducting and evaluating dissolution kinetics, for validation of analytical methods.
During the practical part, participants analyzed case studies, worked on errors, and developed proper approaches to planning, conducting, and documenting the results of bioequivalence demonstration under the biowaiver procedure based on the BCS.
The knowledge gained is an important step toward improving the quality of registration dossier preparation and the effective implementation of science-based strategies for bringing generic medicines to the market.
Upon completion of the training, participants received certificates – the head of the Agency, Doctor of Pharmaceutical Sciences, Professor, Honored Healthcare Worker Oleksandr Hudzenko congratulated them on successfully mastering the topic.
