Last Updated: 09/26/2026
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Found 47 publications
Paediatric developmental safety and the ICH E11A extrapolation of safety.
Journal: British journal of clinical pharmacology
Published: October 03, 2025
Dose Ranging in Pediatric Drug Development Trials Submitted to the US FDA 2012-2020.
Journal: Journal of clinical pharmacology
Published: December 27, 2024
Requirements and special considerations for drug trials with children across six jurisdictions: 1. Clinical trial application review in the regulatory approval process.
Journal: Frontiers in medicine
Published: December 09, 2024
Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process.
Journal: Frontiers in medicine
Published: December 04, 2024
Pediatric Developmental Drug Toxicity: Description of Juvenile Animal Studies in US FDA Prescribing Information and Assessing the Need for New Approach Methodologies.
Journal: Journal of clinical pharmacology
Published: November 24, 2024
Physiologically based Pharmacokinetic/Pharmacodynamic Modeling (PBPK/PD) of Famotidine in Pregnancy.
Physiologically based Pharmacokinetic/Pharmacodynamic Modeling (PBPK/PD) of Famotidine in Pregnancy.
Journal: Journal of clinical pharmacology
Published: September 12, 2024
A Pediatric Research Imperative: Addressing Neonates in Drug Development Through Understanding Neonatal Clinical Pharmacology.
Journal: The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG
Published: March 27, 2024
Labetalol Dosing in Pregnancy: PBPK/PD and CYP2C19 Polymorphisms.
Journal: Journal of clinical pharmacology
Published: January 02, 2024
Development of a Generic Fetal Physiologically Based Pharmacokinetic Model and Prediction of Human Maternal and Fetal Organ Concentrations of Cefuroxime.
Journal: Clinical pharmacokinetics
Published: October 11, 2023
Application of Quantitative Systems Pharmacology to Pediatric Drug Safety Assessment.
Journal: Clinical pharmacology and therapeutics
Published: April 26, 2023
Promoting Clinical Trial Diversity: A Highlight of Select US FDA Initiatives.
Journal: Clinical pharmacology and therapeutics
Published: September 15, 2022
Pediatric Efficacy Extrapolation in Drug Development Submitted to the US Food and Drug Administration 2015-2020.
Journal: Journal of clinical pharmacology
Published: June 05, 2022
Last Updated: 09/26/2026