The Center held a workshop for applicants devoted to comparative pharmacokinetic studies. The topic was covered for the first time as part of the training cycle on bioavailability and bioequivalence.
Comparative pharmacokinetic studies account for more than 95% of all bioequivalence studies and are an integral part of a biosimilar medicinal product development program. The purpose of the training was a detailed analysis of the specifics of conducting such studies, based on regulatory requirements and the leading international guidelines of the EMA and FDA, the specifics of conducting pharmacokinetic studies with regard to their purpose, dosing approaches, analysis of typical errors, and practical aspects of the study.
Given the relevance of the topic, the training was useful both for beginners and for highly experienced specialists.
In total, about 30 participants took part – heads of units engaged in the development of medicinal products, planning and conducting studies, and preparing dossiers for medicinal product registration.
The training was delivered by highly qualified specialists of the Department for Expert Evaluation of Bioavailability and Bioequivalence Materials of the Center – Nadiia ZHUKOVA and Oksana NAHORNIAK.
During the seminar, our experts:
- provided general information on the main current provisions on bioavailability and bioequivalence;
- explained the specifics of the requirements for proving generic status depending on the dosage form, as well as the relationship between pharmaceutical equivalence and bioequivalence;
- drew attention to approaches to selecting and justifying a reference medicinal product, typical mistakes in selecting a reference product, and examples of searching for reference medicinal products;
- focused in detail on approaches to dose selection when conducting a study, and examined possible situations concerning single-component and multi-component medicinal products;
- covered the specifics of designs, standardization, and evaluation criteria for comparative pharmacokinetic studies, taking into account the purpose of the study;
- described the requirements of the specific EMA and FDA bioequivalence guidelines and the differences in approaches;
- drew attention to the expected changes in accordance with the updated ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms and to the main differences in the new version of the EMA guideline on bioanalytical method validation and study sample analysis;
- demonstrated, using specific examples, typical errors in studies, as well as in completing the Clinical Trial Report for medicinal products.
To consolidate the knowledge, the speakers held a practical group session in which participants demonstrated the generic status of medicinal products depending on the dosage form and also selected doses for conducting studies in various situations. Together with the experts, they worked through the most problematic points in completing the tasks and received answers to their questions.
At the end of the course, all participants received certificates and thanked the organizers for the knowledge gained.
It is worth noting that this is already the sixth certified offline seminar within the bioavailability and bioequivalence cycle that our specialists have held this year.
Organizer of the training: the Agency for Methodological and Scientific-Practical Work of the SEC.
