Scientific and Regulatory Considerations for an Ontogeny Knowledge Base for Pediatric Clinical Pharmacology-Reference-Cited by-同舟云学术

Scientific and Regulatory Considerations for an Ontogeny Knowledge Base for Pediatric Clinical Pharmacology

Published:2020-01-26 Issue:4 Volume:107 Page:707-709
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Burckart Gilbert J.¹,Seo Shirley¹,Pawlyk Aaron C.²,McCune Susan K.³,Yao Lynne P.⁴,Giacoia George P.²,Wang Yaning¹,Zineh Issam¹

Affiliation:

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

2. Obstetric and Pediatric Pharmacology and Therapeutics Branch Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health Bethesda Maryland USA

3. Office of Pediatric Therapeutics Office of the Commissioner US Food and Drug Administration Silver Spring Maryland USA

4. Office of New Drugs Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1763

Reference10 articles.

1. Pediatric ontogeny: moving from translational science to drug development;Burckart G.J.;J. Clin. Pharmacol.,2019

2. Pediatric renal ontogeny and applications in drug development;Zhang Y.;J. Clin. Pharmacol.,2019

3. Incorporating ontogeny in physiologically based pharmacokinetic modeling to improve pediatric drug development: what we know about developmental changes in membrane transporters;Cheung K.W.K.;J. Clin. Pharmacol.,2019

4. Distribution of VIP mRNA and two distinct VIP binding sites in the developing rat brain: Relation to ontogenic events

5. European Medicines Agency. Reflection paper on the use of extrapolation in the development of medicines for paediatrics. Accessed December 4 2019.

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