The Center held a bioequivalence seminar, “Biowaiver Based on the BCS.” Organizer: the Agency for Methodological and Scientific-Practical Work of the State Expert Center.
This is the third in a series of offline seminars held by the Center for applicants on topics devoted to conducting bioavailability studies and demonstrating bioequivalence of medicinal products.
The training program was valuable in presenting updated approaches to demonstrating bioequivalence via the biowaiver procedure based on the biopharmaceutics classification system in accordance with the requirements of the guideline “ICH M9 Guideline on biopharmaceutics classification system-based biowaivers,” recommendations for preparing a bioequivalence demonstration report under the biowaiver procedure based on BCS, and analysis of typical errors.
The course was prepared and delivered by specialists of the Department for Expert Evaluation of Bioavailability and Bioequivalence Materials of the Center – Nadiia ZHUKOVA and Oksana NAHORNIAK.
During the introductory part of the seminar, the speakers:
- provided general information on approaches to proving bioequivalence.
- drew attention to approaches to justifying the reference product and typical errors in selecting a reference product, and presented the main sources of information for finding reference products.
- described the main approaches to proving bioequivalence under the biowaiver procedure based on the Biopharmaceutics Classification System (BCS) in accordance with the requirements of the guideline “ICH M9 Guideline on biopharmaceutics classification system-based biowaivers”.
- reviewed the requirements for determining the solubility of an active substance according to the BCS and for determining equilibrium solubility.
- drew attention to the main requirements for assessing the permeability of the active substance, in particular using Caco-2 cells.
- examined in detail the updated requirements for excipients in medicinal products when using the BCS-based biowaiver procedure to demonstrate bioequivalence.
- informed about the requirements for conducting and evaluating dissolution kinetics of medicinal products, as well as the requirements for validation of analytical procedures.
- presented the main requirements for preparing a bioequivalence report under the biowaiver procedure based on the BCS, and demonstrated typical errors in such demonstration using real examples.
To consolidate the knowledge, a practical group session was held with the seminar participants, during which each group worked out and presented an algorithm for developing a generic medicinal product for which bioequivalence was demonstrated under the BCS-based biowaiver procedure.
In total, 20 participants from leading pharmaceutical companies of Ukraine took part in the event – managers and specialists involved in medicinal product development, planning and conducting studies, and subsequent registration of products on the market. Following the seminar, all received certificates and noted the high practical value of the event and the professionalism of the speakers.
Concluding the event, the Head of the Agency for Methodological and Scientific-Practical Work – Doctor of Pharmaceutical Sciences, Professor, Honored Healthcare Worker Oleksandr HUDZENKO noted the importance of education and continuous professional development of healthcare workers. He called on those present to join the training provided by the Center – external thematic seminars in the areas of the Center's activities, as well as seminars for doctors and pharmacists within the continuous professional development (CPD) system with the award of corresponding points. Registration for both groups of training is actively ongoing.
Training schedule for applicants in November here https://m.facebook.com/story.php?story_fbid=705506211610788&id=100064542465652
More about attending CPD seminars at the Center, conditions and registration at the link https://bpr.dec.gov.ua/
