Exploring the Knowledge Gaps in Infant Drug Exposure From Human Milk: A Clinical Pharmacology Perspective-Reference-Cited by-同舟云学术

Exploring the Knowledge Gaps in Infant Drug Exposure From Human Milk: A Clinical Pharmacology Perspective

Published:2022-11-23 Issue:3 Volume:63 Page:273-276
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharma

Author:

Guinn Daphne¹,Pressly Michelle A.¹^ORCID,Liu Zhichao²,Ceresa Carrie³,Samuels Sherbet¹,Wang Yow‐Ming¹,Madabushi Rajanikanth¹,Schmidt Stephan⁴,Fletcher Elimika Pfuma¹

Affiliation:

1. Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

2. National Center for Toxicological Research Food and Drug Administration Jefferson Arkansas USA

3. Division of Pediatrics and Maternal Health Office of Rare Diseases Pediatrics Urologic and Reproductive Medicine Office of New Drugs Center for Drug Evaluation and Research Silver Spring Maryland USA

4. Department of Pharmaceutics Center for Pharmacometrics and Systems Pharmacology University of Florida Orlando Florida USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.2177

Reference12 articles.

1. Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary

2. Evaluation of Drug Labels Following the 2015 Pregnancy and Lactation Labeling Rule

3. 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 Draft Guidance.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.

4. A Review of Adverse Reactions in Infants From Medications in Breastmilk

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1. Transfer of the Dual Orexin Receptor Antagonist Daridorexant into Breast Milk of Healthy Lactating Women;The Journal of Clinical Pharmacology;2024-05-12

2. Dose Optimization Informed by PBPK Modeling: State‐of‐the Art and Future;Clinical Pharmacology & Therapeutics;2024-04-30

3. Clinical Lactation Studies of Neuropsychiatric Medications: Clinical Pharmacology and Labeling Considerations;The Journal of Clinical Pharmacology;2023-06