Open Access
Clinical lactation studies. Acting on key recommendations over the last decade
Karen Rowland Yeo
1
,
Jacqueline Gerhart
2
,
Aarti Sawant-Basak
3
,
Francis Williams Ojara
4, 5
,
Aida N Kawuma
4
,
Catriona Waitt
4, 6
1
Certara UK Limited (CPT Division), Sheffield, UK
|
2
Pfizer Inc, Research and Development, 500 Arcola Road, Collegeville, USA
|
3
AstraZeneca, 35 GateHouse Drive, Waltham, USA
|
Publication type: Journal Article
Publication date: 2025-02-28
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.
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Rowland Yeo K. et al. Clinical lactation studies. Acting on key recommendations over the last decade // npj Women s Health. 2025. Vol. 3. No. 1. 19
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Rowland Yeo K., Gerhart J., Sawant-Basak A., Ojara F. W., Kawuma A. N., Waitt C. Clinical lactation studies. Acting on key recommendations over the last decade // npj Women s Health. 2025. Vol. 3. No. 1. 19
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TY - JOUR
DO - 10.1038/s44294-025-00064-0
UR - https://www.nature.com/articles/s44294-025-00064-0
TI - Clinical lactation studies. Acting on key recommendations over the last decade
T2 - npj Women s Health
AU - Rowland Yeo, Karen
AU - Gerhart, Jacqueline
AU - Sawant-Basak, Aarti
AU - Ojara, Francis Williams
AU - Kawuma, Aida N
AU - Waitt, Catriona
PY - 2025
DA - 2025/02/28
PB - Springer Nature
IS - 1
VL - 3
SN - 2948-1716
ER -
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@article{2025_Rowland Yeo,
author = {Karen Rowland Yeo and Jacqueline Gerhart and Aarti Sawant-Basak and Francis Williams Ojara and Aida N Kawuma and Catriona Waitt},
title = {Clinical lactation studies. Acting on key recommendations over the last decade},
journal = {npj Women s Health},
year = {2025},
volume = {3},
publisher = {Springer Nature},
month = {feb},
url = {https://www.nature.com/articles/s44294-025-00064-0},
number = {1},
pages = {19},
doi = {10.1038/s44294-025-00064-0}
}