Demonstration of Quality, Safety and Efficacy of Biological Products Subject to Changes in Their Manufacturing Process

Ensuring quality, safety and efficacy of the medicinal products placed on the market of the Russian Federation constitutes the area that requires strict regulation. When changes are made to the manufacturing process, the manufacturer generally needs to evaluate the relevant quality attributes of the...

Full description

Saved in:
Bibliographic Details
Main Authors: A. N. Asiliev, E. V. Gavrishina, R. R. Niyazov, A. A. Snegireva, V. K. Adonin
Format: Article
Language:Russian
Published: LLC "Publishing House OKI" 2020-05-01
Series:Антибиотики и Химиотерапия
Subjects:
Online Access:https://www.antibiotics-chemotherapy.ru/jour/article/view/510
Tags: Add Tag
No Tags, Be the first to tag this record!