Preparation of laboratory kits for conducting clinical trials
Preparation of laboratory instructions for research center staff. Preparation of visit-specific laboratory kits for the collection of test samples for all types of studies (pharmacokinetic studies, pharmacodynamics, immunogenicity, safety and efficacy parameters, etc.)
9
chromatograph mass spectrometers
that allow for high-precision determination of low-molecular compounds in biological samples
500+
research
on bioequivalence and pharmacokinetics of medicinal products implemented by the laboratory
ISO 9001
Management System
is certified for compliance with the standard of Good Laboratory Practice (GLP) principles
Other services within the scope of the direction clinical studies
01
Pharmacokinetics of small molecules
02
Pharmacokinetics of biotechnological drugs
03
Pharmacodynamics of biotechnological drugs
04
Immunogenicity of biotechnological drugs
05
Central laboratory (safety and efficacy parameters)
06
Statistical processing (BE, I, II, III phases)
07
Comparative Dissolution Kinetics Test (CDK)
08
Biowaiver
09
Provision of specific reagents, consumables
Смотрите так же
Доклинические исследования
01
Проведение исследований фармакокинетики на животных
Клинические исследования
02
Проведение исследований биоэквивалентности и ранних фаз клинических исследований
Фармацевтический анализ лекарственных препаратов и БАД
03
Разработка и валидация методик нормативной документации: подлинность, количественное содержание, однородность дозирования, примеси, растворение