Clinical lactation studies. Acting on key recommendations over the last decade.

Rowland Yeo, Karen, Gerhart, Jacqueline, Sawant-Basak, Aarti, Ojara, Francis Williams, Kawuma, Aida N and Waitt, Catriona ORCID: 0000-0003-0134-5855 (2025) Clinical lactation studies. Acting on key recommendations over the last decade. npj women's health, 3 (1). p. 19. ISSN 2948-1716, 2948-1716

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Abstract

Including lactating women in clinical trials is imperative to generate relevant drug exposure and safety data needed to advise on clinical use of drugs in this understudied population. Recent changes in perspectives, regulatory guidance, and international networks which outline pragmatic approaches for advancing the conduct of clinical lactation studies are discussed. Case studies demonstrating successful application of modeling and simulation to complement clinical lactation data for enhanced knowledge of infant drug exposure are presented.

Item Type:	Article
Uncontrolled Keywords:	Drug therapy, Reproductive biology
Divisions:	Faculty of Health & Life Sciences Faculty of Health & Life Sciences > Inst. Life Courses & Medical Sciences
Depositing User:	Symplectic Admin
Date Deposited:	24 Mar 2025 08:41
Last Modified:	24 Mar 2025 08:41
DOI:	10.1038/s44294-025-00064-0
Related Websites:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3190920
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