Expert Evaluation of Preclinical Toxicokinetic Studies of Pharmaceuticals (Review)


Дәйексөз келтіру

Толық мәтін

Ашық рұқсат Ашық рұқсат
Рұқсат жабық Рұқсат берілді
Рұқсат жабық Тек жазылушылар үшін

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

Қосымша файлдар

Қосымша файлдар
Әрекет
1. JATS XML

© Springer Science+Business Media, LLC, part of Springer Nature, 2018