Organisation of the Work of Bioanalytical Laboratories according to the Principles of Good Clinical Laboratory Practice (Review)

INTRODUCTION. Bioanalytical laboratories in the Russian Federation should follow the requirements of both the Good Laboratory Practices (GLP), when performing tests for non-clinical studies, and the Good Clinical Practices (GCP), when analysing samples from clinical studies. The work of such laborat...

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Autor principal:	I. S. Giba
Formato:	Artigo
Idioma:	Russo
Publicado em:	Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2024-11-01
coleção:	Регуляторные исследования и экспертиза лекарственных средств
Assuntos:	gclp good clinical laboratory practices bioanalysis bioequivalence study efficacy and safety non-clinical studies clinical trials development of analytical procedures validation of analytical procedures quality management system bioanalytical laboratories glp requirements good laboratory practices gcp requirements good clinical practices
Acesso em linha:	https://www.vedomostincesmp.ru/jour/article/view/645
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