Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling-Reference-Cited by-同舟云学术

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Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling

Published:2016-04-14 Issue:7 Volume:44 Page:924-933
ISSN:1521-009X
Container-title:Drug Metabolism and Disposition
language:en
Short-container-title:Drug Metabolism and Disposition

Author:

Mehrotra N.,Bhattaram A.,Earp J. C.,Florian J.,Krudys K.,Lee J. E.,Lee J. Y.,Liu J.,Mulugeta Y.,Yu J.,Zhao P.,Sinha V.

Publisher

American Society for Pharmacology & Experimental Therapeutics (ASPET)

Subject

Pharmaceutical Science,Pharmacology

Reference32 articles.

1. Physiologically Based Pharmacokinetic (PBPK) Modeling in Children

2. Pediatric Antihypertensive Trial Failures

3. Impact of Pharmacometric Reviews on New Drug Approval and Labeling Decisions—a Survey of 31 New Drug Applications Submitted Between 2005 and 2006

4. Impact of pharmacometrics on drug approval and labeling decisions: A survey of 42 new drug applications

5. Development and Evaluation of a Generic Physiologically Based Pharmacokinetic Model for Children

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4. Dose rationale for gabapentin and tramadol in pediatric patients with chronic pain;Pharmacology Research & Perspectives;2023-10

5. Application of Modelling and Simulation Approaches to Predict Pharmacokinetics of Therapeutic Monoclonal Antibodies in Pediatric Population;Pharmaceutics;2023-05-20

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