[International clinical trials of vaccines].
Modern principles of organization and planning of international clinical trials of vaccines and stages of development of domestic vaccines are presented. Factors that determine the success of large-scale clinical trials are thoroughly described. Differences between domestic registration trials and international multicenter randomized clinical trials are discussed. It has been recommended how national regulatory acts that legitimate conducting of clinical trials of both national and foreign vaccines should be harmonized.
Mikhaĭlova
N A
NA
Tatochenko
V K
VK
Smolenov
I V
IV
D002986:Clinical Trials as Topic / Q000592:standards*; D017277:Drug Approval; D015195:Drug Design; D017408:Guidelines as Topic; D006801:Humans; D012106:Research; D012426:Russia; D014612:Vaccines
D014612:Vaccines