Регуляторные исследования и экспертиза лекарственных средств (Feb 2018)
Clinical trials in pregnancy: evaluation of benefit/risk?
Abstract
In terms of pharmacotherapy, pregnancy is a specific phase of life that is different from all the other phases of the life of medical, ethical and legal framework. The article examines the scientific, ethical and regulatory principles of inclusion of pregnant women in the clinical trials of drugs, the necessity for them is justified from the point of clinical pharmacology. The clinical value assessment studies regarding the expected benefits to the possible risks during the pharmacotherapy in pregnancy necessitates the development of this scientific direction.
