Role of Model‐Informed Drug Development in Pediatric Drug Development, Regulatory Evaluation, and Labeling

Model-Informed Drug Development: Current U.S. Regulatory Practice and Future Considerations

(2019) Yaning Wang et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Model-informed drug development approach supporting approval of the 4-week (Q4W) dosing schedule for nivolumab (Opdivo) across multiple indications: a regulatory perspective

(2019) Y Bi et al.   ANNALS OF ONCOLOGY

Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration’s Office of Clinical Pharmacology

(2018) Manuela Grimstein et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Bioequivalence Comparison of Pediatric Dasatinib Formulations and Elucidation of Absorption Mechanisms Through Integrated PBPK Modeling

(2018) Shruthi Vaidhyanathan et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Esomeprazole FDA Approval in Children With GERD

(2017) Justin C. Earp et al.   JOURNAL OF PEDIATRIC GASTROENTEROLOGY AND NUTRITION

Failed Pediatric Drug Development Trials

(2015) JD Momper et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Clinical Pharmacology and the Catalysis of Regulatory Science: Opportunities for the Advancement of Drug Development and Evaluation

(2013) I Zineh et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Adolescent Dosing and Labeling Since the Food and Drug Administration Amendments Act of 2007

(2013) Jeremiah D. Momper et al.   JAMA Pediatrics

Pediatric Information in Drug Product Labeling

(2012) Debbie Avant   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions

(2011) Joo Yeon Lee et al.   CLINICAL PHARMACOKINETICS

Pharmacokinetics of Antiretroviral Drug Varies With Formulation in the Target Population of Children With HIV-1

(2011) P Kasirye et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Clarification on Precision Criteria to Derive Sample Size When Designing Pediatric Pharmacokinetic Studies

(2011) Yaning Wang et al.   JOURNAL OF CLINICAL PHARMACOLOGY

Clinical Pharmacology in the Adolescent Oncology Patient

(2010) Gareth J. Veal et al.   JOURNAL OF CLINICAL ONCOLOGY

Mechanistic Basis of Using Body Size and Maturation to Predict Clearance in Humans

(2009) Brian J. Anderson et al.   Drug Metabolism and Pharmacokinetics

Leveraging Prior Quantitative Knowledge to Guide Drug Development Decisions and Regulatory Science Recommendations: Impact of FDA Pharmacometrics During 2004-2006

(2008) Yaning Wang et al.   JOURNAL OF CLINICAL PHARMACOLOGY