Expert Evaluation of Preclinical Toxicokinetic Studies of Pharmaceuticals (Review)
- Авторлар: Syubaev R.D.1, Engalycheva G.N.1, Goryachev D.V.1, Sokolov A.V.1, Chistyakov V.V.1, Stepanova E.S.1
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Мекемелер:
- Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
- Шығарылым: Том 52, № 9 (2018)
- Беттер: 753-757
- Бөлім: Molecular-Biological Problems of Drug Design and Mechanism of Drug Action
- URL: https://ogarev-online.ru/0091-150X/article/view/245450
- DOI: https://doi.org/10.1007/s11094-018-1894-2
- ID: 245450
Дәйексөз келтіру
Аннотация
Literature data and domestic and foreign methodological documentation for preclinical studies of the safety and toxicokinetics of pharmaceuticals are analyzed. According to Marketing Authorization and Assessment Rules for Medicinal Products in the EAEU, a developer must include in a General Technical Document information on toxicokinetic studies that is evaluated during a review of preclinical test results. The main approaches to expert evaluation of drug toxicokinetic studies are formulated. The main content of the expert analysis includes the methodological basis and results of the research, safety profile characteristics, extrapolation of preclinical data, risk factor characteristics, and predicted clinical patient safety profile. The inclusion of toxicokinetic studies in a program of preclinical toxicological studies is important in principle for an adequate extrapolation of experimental data and prediction of the safety of pharmaceuticals in humans. Expert analysis of toxicokinetic data allows toxicology study results, drug toxicity profile characteristics, and the risk of toxic side effects to be interpreted correctly.
Авторлар туралы
R. Syubaev
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Хат алмасуға жауапты Автор.
Email: Subaev@expmed.ru
Ресей, Moscow, 127051
G. Engalycheva
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: Subaev@expmed.ru
Ресей, Moscow, 127051
D. Goryachev
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: Subaev@expmed.ru
Ресей, Moscow, 127051
A. Sokolov
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: Subaev@expmed.ru
Ресей, Moscow, 127051
V. Chistyakov
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: Subaev@expmed.ru
Ресей, Moscow, 127051
E. Stepanova
Scientific Center for Expert Evaluation of Medicinal Products, Ministry of Health of the Russian Federation
Email: Subaev@expmed.ru
Ресей, Moscow, 127051
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