Evaluation of the Safety of Drugs and Biological Products Used During Lactation: Workshop Summary
| Autor: | Jian Wang, Leyla Sahin, Robert M. Nelson, D Johnson-Lyles, Teresa Baker, Thomas W. Hale, Tamara Johnson, Lynne Yao, J Sauberan, Philip O. Anderson, C Nguyen, Gilbert J. Burckart, S Ito, Zhaoxia Ren, Tassinari, Christina Bucci-Rechtweg, Hari Cheryl Sachs, D Pica-Branco, Christina D. Chambers, Anne Zajicek |
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| Rok vydání: | 2017 |
| Předmět: |
medicine.medical_specialty
Drug-Related Side Effects and Adverse Reactions Consensus Development Conferences as Topic education MEDLINE Alternative medicine Pharmacology Models Biological Risk Assessment Article Food and drug administration 03 medical and health sciences 0302 clinical medicine Models Pregnancy Risk Factors 030225 pediatrics Lactation medicine Humans Pharmacology (medical) Pharmacology & Pharmacy 030212 general & internal medicine Pediatric Biological Products business.industry Infant Newborn Infant Pharmacology and Pharmaceutical Sciences Congresses as Topic Biological Newborn Breast Feeding medicine.anatomical_structure Maternal Exposure Family medicine Female business Risk assessment |
| Zdroj: | Clinical pharmacology and therapeutics, vol 101, iss 6 |
| ISSN: | 0009-9236 |
| DOI: | 10.1002/cpt.676 |
| Popis: | This report serves as a summary of a 2-day public workshop sponsored by the US Food and Drug Administration (FDA) to discuss the safety of drugs and biological products used during lactation. The aim of the workshop was to provide a forum to discuss the collection of data to inform the potential risks to breastfed infants with maternal use of medications during lactation. Discussions included the review of current approaches to collect data on medications used during lactation, and the considerations for future approaches to design and guide clinical lactation studies. This workshop is part of continuing efforts to raise the awareness of the public for women who choose to breastfeed their infants. |
| Databáze: | OpenAIRE |
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