On October 26, 2023 Dmitry Grebenkin, Ph.D., Head of Exacte Labs Biotech Drug Research Laboratory, will give an online presentation on "Bioanalytical studies of biomolecules: peculiarities of preparation" at the conference "Dialogues on Clinical Trials". The report will be presented in the section: "Bioequivalence studies 2023: theory and practice".
As part of the report Dmitry will address the following questions:
- What is understood by biologics;
- What is investigated for biologics in vivo, according to what rules;
- Studying pharmacokinetics of biologics: main differences from bioanalytics for small molecules;
- Immunogenicity studies, method validation: basic concepts and approaches;
- The problem of dependence on reagents and positive controls: what it is and ways to overcome it;
- The main problems with planning timelines and work budgets (procurement, workload, method development).
The conference "Dialogues on Clinical Trials" is dedicated to the topical issues of clinical trials, as well as the main challenges, regulatory changes and solutions to ensure continuity of the processes of development and withdrawal of medicinal products in the Russian Federation.