Current Status of Pharmacokinetic Research of Clinical Trial Records in the Female Population in India: A Systematic Review

Abstract

Background: Pharmacological treatment influence men and women in distinct ways. Over the last decade, pharmacological research has significantly enhanced our understanding of many elements determining medicine prescription. The objective of this study is to carefully assess the clinical pharmacokinetic studies involved female subjects in India. Methods: We conducted a systematic review to assess clinical trial records' pharmacokinetic data in the female population of all age groups. The keywords 'pharmacokinetics’ or 'pharmacokinetic parameters’ or ‘bioavailability’ was used in the clinicaltrials.gov website and clinical trial registry of India [CTRI] website to find eligible clinical trials or records carried out between January 1, 2000 and June 30, 2022. Interventional studies, pharmacokinetics, pharmacokinetic parameters, bioavailability, female participants, India were all included in an advanced search filter on the two websites. Results: In a total of 714 records, 17 (2.4%) records of interventional clinical trials with pharmacokinetic data involving the female population were assessed. All 17 trials were conducted in 15 research settings, with 27.3% of studies conducted in Maharashtra, followed by Karnataka (12.7%) and New Delhi (9.1%). A total of 30 pharmacokinetic parameters were studied in trials with peak concentration (C max) and area under the curve (AUC) of plasma or tissue concentration, accounting for 23.3% of the trials. The majority of drug trials focused on treating neoplasms accounted for 14 trials (76.4%). Conclusions: This review provides an overview of the current status and gaps in pharmacokinetic research in female populations. More studies should be conducted to properly examine the often limited data available on pharmacokinetic studies to guide trial design to make future clinical trials feasible and economical