Results 11 to 16 of about 16 (16)

The history of development of Pharmacopoeia standards quality biological drugs and methods of tests in Russia

open access: yesБиопрепараты: Профилактика, диагностика, лечение, 2018
The Russian system of standardization of HP including biological medicines is based on the State Pharmacopoeia of the Russian Federation numbering more than the 250th summer history of the development.
T. M. Kargina   +3 more
doaj  

The state pharmacopoeia in the system of higher education

open access: yesРегуляторные исследования и экспертиза лекарственных средств, 2018
The article provides with a brief historical background for the editions of the State Pharmacopoeia. It characterizes the Russian State Pharmacopoeia of the XIII edition.
I. I. Krasnyuk, N. B. Demina
doaj  

The development of the monographs for compoundED preparations for the state pharmacopoeia of Ukraine

open access: yesРегуляторные исследования и экспертиза лекарственных средств, 2018
At present, there are certain topical issues related to the development of the standards for preparation and quality control of compounded medicines, the elaboration of quality assurance system for compounded preparations under the state policy ...
A. A. Zdoryk   +3 more
doaj  

Determination of visible particles in parenteral dosage forms and ophthalmic dosage forms

open access: yesРегуляторные исследования и экспертиза лекарственных средств, 2018
The present article describes the approaches to the choice of methods for assessing the content of visible particles in parenteral and ophthalmic dosage forms, recognized in general pharmacopoeia monograph «Visible particles in parenteral dosage forms ...
Yu. V. Olefir   +7 more
doaj  

Certification and shelf-life extension of a new batch of the branch reference standard for live tularemic vaccine's specific activity and immunogenicity

open access: yesБиопрепараты: Профилактика, диагностика, лечение, 2018
The article presents the results obtained in the study of a new batch of a candidate branch reference standard for live tularemic vaccine (vaccine BRS). The candidate vaccine BRS was represented by a commercial batch of a product that met all applicable ...
I. V. Kasina   +9 more
doaj  

Accelerating Global Deletion of the Abnormal Toxicity Test for vaccines and biologicals. Planning common next steps. A workshop Report.

open access: yesBiologicals, 2022
Viviani L   +36 more
europepmc   +1 more source

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