Generic, hybrid, or fixed combination: approaches to the scope of studies. Center specialists held a workshop for representatives of the pharmaceutical market. In total, 33 participants took part.
The event was held as part of the Center’s external training activities, organized by the Agency for Methodological and Scientific-Practical Work of the Center. The course of lectures and practical assignments was delivered by specialists of the Directorate for Expert Evaluation of Bioavailability and Bioequivalence Materials of the Center – head of the unit, PhD in Pharmacy Nadiia ZHUKOVA, and expert of the Division for Expert Evaluation of Materials on Generic and Other Medicinal Products Oksana NAHORNIAK.
During the training, participants became familiar with:
- approaches to choosing the type of state registration application, and worked through various algorithms for proving the type of a medicinal product depending on its properties;
- approaches to the scope of studies for determining the type of medicinal product (generic, hybrid, fixed combination);
- approaches to selecting and justifying a reference product (with analysis of errors and examples of information searches);
- features of studies if a medicinal product has several dosages (with examples of situations)
- peculiarities of procedures for demonstrating genericity – pharmaceutical equivalence, comparative pharmacokinetic studies, BCS-based biowaiver procedure, etc. (with examples).
During the practical part, the audience practiced analyzing case studies – determining the type of registration form and the scope of studies depending on the intended use of the medicinal product and its dosage.
"This knowledge is conceptual in the context of the pharmaceutical development of a medicinal product. Choosing the right study and conducting it correctly will help applicants avoid mistakes at the subsequent registration stage," stressed Nadiia ZHUKOVA.
Upon completion, all participants received certificates.
For your information:
The list of upcoming seminars can be found on the Center's website in the Training Events section https://www.dec.gov.ua/
See the list of the Center's upcoming CPD events on the dedicated page at the link https://bpr.dec.gov.ua/
