Methodological and regulatory aspects of pharmaceutical development of biological products

Methodological and regulatory aspects of pharmaceutical development of biological products

The aim of the work was to conduct an analysis of the current state and current trends in the approval of drugs, as well as some aspects of the methodology for their development based on biological molecules and registration.Materials and methods. The material for the analysis was taken from the abs...

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Main Authors: D. V. Kurkin, E. I. Morkovin, D. A. Bakulin, A. V. Zaborovsky, I. E. Makarenko, R. V. Drai, A. G. Solodovnikov, V. I. Petrov, K. N. Koryanova, N. A. Lycheva, S. A. Voskresensky, A. V. Strygin, Yu. A. Kolosov, Yu. V. Gorbunova, O. V. Ivanova
Format: Article
Language:Russian
Published: Volgograd State Medical University, Pyatigorsk Medical and Pharmaceutical Institute 2024-01-01
Series:Фармация и фармакология (Пятигорск)
Subjects:
biologics
biosimilars
biomolecules
regulation
development and registration
u.s. food and drug administration
Online Access:https://www.pharmpharm.ru/jour/article/view/1392
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