Exploring the Knowledge Gaps in Infant Drug Exposure From Human Milk: A Clinical Pharmacology Perspective
- PMID: 36355399
- DOI: 10.1002/jcph.2177
Exploring the Knowledge Gaps in Infant Drug Exposure From Human Milk: A Clinical Pharmacology Perspective
Keywords: exposure; lactation; ontogeny; pediatrics.
References
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- Wang J, Johnson T, Sahin L, et al. Evaluation of the safety of drugs and biological products used during lactation: workshop summary. Clin Pharmacol Ther. 2017;101(6):736-744.
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- Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products- Content and Format. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER); 2020.
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- Byrne JJ, Saucedo AM, Spong CY. Evaluation of drug labels following the 2015 pregnancy and lactation labeling rule. JAMA Network Open. 2020;3(8):e2015094-e2015094.
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- Clinical Lactation Studies: Considerations for Study Design. Draft Guidance. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER); 2019.
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- Anderson PO, Manoguerra AS, Valdés V. A review of adverse reactions in infants from medications in breastmilk. Clin Pediatr. 2015;55(3):236-244.
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