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Current Women`s Health Reviews

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ISSN (Print): 1573-4048
ISSN (Online): 1875-6581

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Systematic Review Article

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

Author(s): Hemasri Velmurugan and Pugazhenthan Thangaraju*

Volume 20, Issue 2, 2024

Published on: 12 May, 2023

Article ID: e200423216142 Pages: 10

DOI: 10.2174/1573404820666230420113904

Price: $65

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%).

Conclusion: 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.

Graphical Abstract

[1]
Tanaka E. Gender-related differences in pharmacokinetics and their clinical significance. J Clin Pharm Ther 1999; 24(5): 339-46.
[http://dx.doi.org/10.1046/j.1365-2710.1999.00246.x] [PMID: 10583696]
[2]
Meibohm B, Derendorf H. Pharmacokinetic/pharmacodynamic studies in drug product development. J Pharm Sci 2002; 91(1): 18-31.
[http://dx.doi.org/10.1002/jps.1167] [PMID: 11782894]
[3]
Waxman DJ, Holloway MG. Sex differences in the expression of hepatic drug metabolizing enzymes. Mol Pharmacol 2009; 76(2): 215-28.
[http://dx.doi.org/10.1124/mol.109.056705] [PMID: 19483103]
[4]
Carrasco-Portugal MC, Flores-Murrieta FJ. Gender differences in the pharmacokinetics of oral drugs. Pharmacol Pharm 2011; 2(1): 31-41.
[http://dx.doi.org/10.4236/pp.2011.21004]
[5]
Jeong H. Altered drug metabolism during pregnancy: Hormonal regulation of drug-metabolizing enzymes. Expert Opin Drug Metab Toxicol 2010; 6(6): 689-99.
[http://dx.doi.org/10.1517/17425251003677755] [PMID: 20367533]
[6]
Chu T. Gender differences in pharmacokinetics. US Pharm 2014; 39(9): 40-3.
[7]
Soldin OP, Mattison DR. Sex differences in pharmacokinetics and pharmacodynamics. Clin Pharmacokinet 2009; 48(3): 143-57.
[http://dx.doi.org/10.2165/00003088-200948030-00001] [PMID: 19385708]
[8]
Svensson CK, Woodruff MN, Baxter JG, Lalka D. Free drug concentration monitoring in clinical practice. Rationale and current status. Clin Pharmacokinet 1986; 11(6): 450-69.
[http://dx.doi.org/10.2165/00003088-198611060-00003] [PMID: 3542337]
[9]
Franconi F, Campesi I. Pharmacogenomics, pharmacokinetics and pharmacodynamics: Interaction with biological differences between men and women. Br J Pharmacol 2014; 171(3): 580-94.
[http://dx.doi.org/10.1111/bph.12362] [PMID: 23981051]
[10]
Klinge I. Gender perspectives in European research. Pharmacol Res 2008; 58(3-4): 183-9.
[http://dx.doi.org/10.1016/j.phrs.2008.07.011] [PMID: 18761409]
[11]
Wetherington CL. Sex-gender differences in drug abuse: A shift in the burden of proof? Exp Clin Psychopharmacol 2007; 15(5): 411-7.
[http://dx.doi.org/10.1037/1064-1297.15.5.411] [PMID: 17924775]
[12]
Rogers WA, Ballantyne AJ. Exclusion of women from clinical research: Myth or reality? Mayo Clin Proc 2008; 83(5): 536-42.
[http://dx.doi.org/10.1016/S0025-6196(11)60725-8] [PMID: 18452682]
[13]
Hayes SN, Redberg RF. Dispelling the myths: Calling for sex-specific reporting of trial results. Mayo Clin Proc 2008; 83(5): 523-5.
[http://dx.doi.org/10.1016/S0025-6196(11)60722-2] [PMID: 18452679]
[14]
Zucker I, Prendergast BJ. Sex differences in pharmacokinetics predict adverse drug reactions in women. Biol Sex Differ 2020; 11(1): 32.
[http://dx.doi.org/10.1186/s13293-020-00308-5] [PMID: 32503637]
[15]
Pariente G, Leibson T, Carls A, Adams-Webber T, Ito S, Koren G. Pregnancy-associated changes in pharmacokinetics: A systematic review. PLoS Med 2016; 13(11): e1002160.
[http://dx.doi.org/10.1371/journal.pmed.1002160] [PMID: 27802281]
[16]
16. U.S. National Library of Medicine. Clinical trials.. Available from: https://www.clinicaltrials.gov/
[17]
Clinical Trial Registry of India. 2021. Available from: http://www.ctri.nic.in/
[18]
International Classification of Diseases ICD-11 Mortality and Morbidity Statistics (ICD-11 MMS).. Available from: https://icd.who.int/browse11/l-m/en
[19]
World Health Organization Model List of Essential Medicines – 22nd List, 2021. Geneva: World Health Organization 2021. Available from: https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2021.02
[20]
National List of Essential Medicines. 2015. Available from: https://cdsco.gov.in/opencms/opencms/en/consumer/Essential-Medicines/
[21]
Centre releases NLEM 2021 with 39 additional drugs and 16 deletions from previous list.. 2021. Available from: http://www.pharmabiz.com/NewsDetails.aspx?aid=142320&sid=1
[22]
Costantine MM. Physiologic and pharmacokinetic changes in pregnancy. Front Pharmacol 2014; 5: 65.
[http://dx.doi.org/10.3389/fphar.2014.00065] [PMID: 24772083]
[23]
Weiner CP, Buhimschi C, Swaan P. Drug-prescribing challenges during pregnancy. Curr Obstet Gynaecol 2005; 15(3): 157-65.
[http://dx.doi.org/10.1016/j.curobgyn.2005.03.005]
[24]
Pennell PB. Antiepileptic drug pharmacokinetics during pregnancy and lactation. Neurology 2003; 61 (Suppl. 2): S35-42.
[http://dx.doi.org/10.1212/WNL.61.6_suppl_2.S35] [PMID: 14504308]
[25]
Chen H, Yang K, Choi S, Fischer JH, Jeong H. Up-regulation of UDP-glucuronosyltransferase (UGT) 1A4 by 17beta-estradiol: a potential mechanism of increased lamotrigine elimination in pregnancy. Drug Metab Dispos 2009; 37(9): 1841-7.
[http://dx.doi.org/10.1124/dmd.109.026609] [PMID: 19546240]
[26]
Korth-Bradley JM, Parks V, Chalon S, et al. Excretion of moxidectin into breast milk and pharmacokinetics in healthy lactating women. Antimicrob Agents Chemother 2011; 55(11): 5200-4.
[http://dx.doi.org/10.1128/AAC.00311-11] [PMID: 21896908]
[27]
Connor EM, Smoyer WE, Davis JM, et al. Meeting the demand for pediatric clinical trials. Sci Transl Med 2014; 6(227): 227fs11.
[http://dx.doi.org/10.1126/scitranslmed.3008043] [PMID: 24622511]
[28]
Avram MJ. Pharmacokinetic studies in pregnancy. Semin Perinatol 2020; 44(3): 151227.
[http://dx.doi.org/10.1016/j.semperi.2020.151227] [PMID: 32093881]
[29]
Verrest L, Dorlo TPC. Lack of clinical pharmacokinetic studies to optimize the treatment of neglected tropical diseases: A systematic review. Clin Pharmacokinet 2017; 56(6): 583-606.
[http://dx.doi.org/10.1007/s40262-016-0467-3] [PMID: 27744580]

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