THE SPECIFIC FEATURES OF THE PHASE I OF CLINICAL INVESTIGATIONS OF DRUGS
摘要
This article discusses the possibility of clinical research of drugs, identifies the specific features of the phase I of clinical investigations.
关于作者
A. Savchenko俄罗斯联邦
G. Ramenskaya
俄罗斯联邦
V. Kukes
俄罗斯联邦
参考
1. Kola I, Landis J. Can the industry reduce attrition rates? // Nature Rev. Drug Disc. — 2004. — Vol. 3. — 711 p.
2. Lesko L, Atkinson A. Use of biomarkers and surrogate endpoints in drug development // Ann. Rev. Pharmacol. Toxicol. — 2001. — Vol. 41. — P. 347–366.
3. Bioavailability and bioequivalence // CPMP/EWP/QWP. — 1998. — 1401 p.
4. Shah R. QT interval in drug development // Br. J. Clin. Pharmacol. — 2002. — Vol. 54. — P. 188–202.
5. Estimating the safe starting dose for healthy volunteers. — FDA, 2005.
6. Toxicokinetics and exposure in toxicology studies // CPMP/ICH. — 1995. — 384 p.
7. Declaration of Helsinki. — World Medical Association, 1996.
8. Sibille M et al. Is phase 1 still safe? // Br. J. Clin. Pharmacol. — 2006. — Vol. 62. — P. 502–503.