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Drug Utilization Studies in Pregnant Women for Newly Licensed Medicinal Products: A Contribution from IMI ConcePTION.孕妇中新型许可药物的药物利用研究：来自 IMI ConcePTION 的贡献。
J Pregnancy. 2024 Jan 11;2024:8862801. doi: 10.1155/2024/8862801. eCollection 2024.
2
Challenges Related to Acquisition of Physiological Data for Physiologically Based Pharmacokinetic (PBPK) Models in Postpartum, Lactating Women and Breastfed Infants-A Contribution from the ConcePTION Project.产后、哺乳期妇女及母乳喂养婴儿基于生理药代动力学（PBPK）模型的生理数据采集相关挑战——来自ConcePTION项目的贡献
Pharmaceutics. 2023 Nov 12;15(11):2618. doi: 10.3390/pharmaceutics15112618.
3
Pharmacokinetic Evaluation in Pregnancy-Current Status and Future Considerations: Workshop Summary.妊娠期药代动力学评估：现状与未来思考——研讨会总结。
J Clin Pharmacol. 2023 Jun;63 Suppl 1:S7-S17. doi: 10.1002/jcph.2230.
4
Physiologic Changes During Pregnancy and Impact on Small-Molecule Drugs, Biologic (Monoclonal Antibody) Disposition, and Response.妊娠期间的生理变化及其对小分子药物、生物（单克隆抗体）处置和反应的影响。
J Clin Pharmacol. 2023 Jun;63 Suppl 1(Suppl 1):S34-S50. doi: 10.1002/jcph.2227.
5
Addressing drug safety of maternal therapy during breastfeeding using physiologically-based pharmacokinetic modeling.利用基于生理的药代动力学模型解决母乳喂养期间母体治疗的药物安全性问题。
CPT Pharmacometrics Syst Pharmacol. 2022 May;11(5):535-539. doi: 10.1002/psp4.12802. Epub 2022 Apr 28.
6
A Landscape Analysis of Post-Marketing Studies Registered in the EU PAS Register and ClinicalTrials.gov Focusing on Pregnancy Outcomes or Breastfeeding Effects: A Contribution from the ConcePTION Project.欧盟 PAS 注册库和 ClinicalTrials.gov 中注册的上市后研究的景观分析，重点关注妊娠结局或母乳喂养影响：来自 ConcePTION 项目的贡献。
Drug Saf. 2022 Apr;45(4):333-344. doi: 10.1007/s40264-022-01154-7. Epub 2022 Mar 31.
7
Physiologically Based Pharmacokinetics Model in Pregnancy: A Regulatory Perspective on Model Evaluation.孕期基于生理的药代动力学模型：模型评估的监管视角
Front Pediatr. 2021 Jun 23;9:687978. doi: 10.3389/fped.2021.687978. eCollection 2021.
8
PBPK Modeling Approach to Predict the Behavior of Drugs Cleared by Kidney in Pregnant Subjects and Fetus.基于 PBPK 模型预测经肾脏清除的药物在孕妇及胎儿体内行为的方法。
AAPS J. 2021 Jun 24;23(4):89. doi: 10.1208/s12248-021-00603-y.
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Assuring Access to Safe Medicines in Pregnancy and Breastfeeding.保障妊娠和哺乳期安全用药。
Clin Pharmacol Ther. 2021 Oct;110(4):941-945. doi: 10.1002/cpt.2212. Epub 2021 May 1.
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A comprehensive review on non-clinical methods to study transfer of medication into breast milk - A contribution from the ConcePTION project.关于研究药物经母乳转移的非临床方法的全面综述——来自 ConcePTION 项目的贡献。
Biomed Pharmacother. 2021 Apr;136:111038. doi: 10.1016/j.biopha.2020.111038. Epub 2021 Jan 30.

EMA perspective on the value of model-informed drug development for labeling recommendations regarding medicine use during pregnancy and breastfeeding.

作者信息

Manolis Efthymios, Musuamba Flora Tshinanu, de Vries Corinne S, Colin Pieter J, Oleksiewicz Martin B

机构信息

European Medicines Agency, Amsterdam, The Netherlands.

Federal Agency for Medicines and Health Products, Brussel, Belgium.

出版信息

CPT Pharmacometrics Syst Pharmacol. 2024 Nov;13(11):1820-1823. doi: 10.1002/psp4.13214. Epub 2024 Aug 13.

DOI:10.1002/psp4.13214
PMID:39136590
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11578136/
Abstract
摘要