In 21.02.2024, a seminar is scheduled on the topic: “Study of Bioavailability and Bioequivalence – Comparative Pharmacokinetic Studies. Biowaiver for Additional Strengths”, organized by the Agency for Methodological and Scientific-Practical Work of the Center in cooperation with the Division for Expert Evaluation of Bioavailability and Bioequivalence Materials.
📌In the seminar program
- What you need to understand about bioequivalence in the context of the new Law on Medicinal Products.
- Specifics of requirements for proof of generic status depending on the dosage form.
- Approaches to the selection and justification of a reference product.
- Biowaiver for additional dosage strengths (mono and combination medicinal products).
- Features of the designs, standardization and evaluation criteria of comparative pharmacokinetic studies, taking into account the different purposes of the study.
Seminar participation application form
Seminar program
Participation format – offline.
We ask that applications be sent electronically (Word file) to: amsw@dec.gov.ua
Contact person:
Svitlana BORODAI tel: +38 (044) 202-17-00 (2251)
