Authors : Sunil Chaudhry, Sunil Chaudhry, Vishwas Sovani, Vishwas Sovani
DOI : 10.18231/j.ijpp.2021.054
Volume : 8
Issue : 4
Year : 2021
Page No : 301-304
The aim of clinical research is to impart knowledge that will improve human health or improve understanding of human physiology. Although, till the end of 20 century pregnancy was always under exclusion criteria, now pervasive exclusion of pregnant women in clinical trials is currently not justified. Pregnancy brings in an array of anatomical, physiological and biochemical changes that can impact the pharmacokinetics of important medications. Pregnancy is often accompanied by chronic diseases like diabetes, hypertension, tuberculosis, HIV, depression which can require long term therapy. This indicates a need for studies being conducted exclusively in pregnant women. Current communication narrates ethical and regulatory aspects of inclusion of pregnant women in clinical trials.
Keywords: Special populations, Pregnant or nursing women, Pharmacokinetics, Informed consent, Paternal consent