An offline seminar for applicants “Biowaiver Based on the Biopharmaceutics Classification System” took place at the Center – the fourth in a series devoted to studies of bioavailability and demonstration of bioequivalence of medicinal products.
The aim is to familiarize applicants with updated approaches to demonstrating the bioequivalence of generic medicinal products by the biowaiver procedure based on the BCS in accordance with international guidelines, as well as to teach them to apply this knowledge during the development of medicinal products and the preparation of registration dossiers.
30 participants took part – managers and employees of the areas involved in the development of medicinal products.
The event was held by the Agency for Methodological and Scientific-Practical Work of the Center under the guidance of Doctor of Pharmaceutical Sciences, Professor, Honored Health Worker Oleksandr Hudzenko.
The training was conducted by specialists of the Directorate for Expert Evaluation of Bioavailability and Bioequivalence Materials of the Center – Nadiia Zhukova and Oksana Nahorniak.
During the theoretical part of the course, participants familiarized themselves with:
- updated approaches to the selection and justification of the reference product,
- updated approaches to proof of bioequivalence by the BCS-based biowaiver procedure in accordance with the requirements of the guideline “ICH M9 Guideline on biopharmaceutics classification system-based biowaivers”;
- updated requirements for determining the solubility of the active substance according to the BCS;
- requirements for determining equilibrium solubility;
- requirements for excipients;
- peculiarities of preparing bioavailability materials for the indicators absolute bioavailability, mass balance and Caco 2;
- requirements for conducting and evaluating dissolution kinetics;
- requirements for validation of analytical procedures.
During the practical part, participants built an algorithm for developing a generic medicinal product and demonstrating its bioequivalence under the biowaiver procedure based on the Biopharmaceutics Classification System (BCS). Typical errors were reviewed and questions were answered.
Concluding the seminar, the Head of the Agency Oleksandr Hudzenko presented certificates to participants, encouraged them to share feedback and ratings of the event, and invited them to participate in further training.
