Scientific work
More than 50 publications and co-authored monographs on medicinal product research. Participation in the development of EAEU regulatory documents.
Scientific foundation
Dmitry Romodanovsky is the author and co-author of more than 50 scientific publications in the areas of pharmaceutical regulation, bioequivalence, clinical trials, and regulatory requirements. Works are published in peer-reviewed Russian and international journals.
He participated in the development of EAEU guidance documents on bioequivalence studies, clinical trials, and medicinal product evaluation.
Publication areas
Bioequivalence
Methodology of bioequivalence studies, computational methods for dissolution profile similarity assessment, applicability criteria for f2 and Bootstrap methods.
Clinical trials
Documentation requirements for clinical trials, Good Clinical Practice standards, protocol and report preparation.
Regulatory requirements
EAEU regulatory framework for drug registration, evolution of regulatory requirements, comparative analysis.
Drug research
Preclinical and clinical aspects of drug research, methods for evaluating pharmacokinetic parameters.
The full list of publications and links to works are provided upon request. For information about specific publications — contact us.
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