Janelle M. Burnham

A Comparison of Pediatric and Adult Safety Studies for Antipsychotic and Antidepressant Drugs Submitted to the United States Food and Drug Administration

Xiaomei I. Liu, Paul Schuette, Gilbert J. Burckart et al. · The Journal of Pediatrics · 2019 · 49 citations · Full text

Drug Safety, Psychiatry, Medicine +12

Monoclonal Antibodies and Fc‐Fusion Proteins for Pediatric Use: Dosing, Immunogenicity, and Modeling and Simulation in Data Submitted to the US Food and Drug Administration

Xiaomei I. Liu, André Dallmann, Yow‐Ming Wang et al. · The Journal of Clinical Pharmacology · 2019 · 33 citations · Full text

Immunohematology, Allergy Medicine, Immunodeficiencies +23

Primary Endpoints in Pediatric Efficacy Trials Submitted to the US FDA

Dionna J. Green, Janelle M. Burnham, Paul Schuette et al. · The Journal of Clinical Pharmacology · 2018 · 24 citations · Full text

Clinical Endpoint, Pediatric Efficacy Trials, Appropriate Endpoints +23

Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012–2018

Irin Tanaudommongkon, Shogo John Miyagi, Dionna J. Green et al. · Clinical Pharmacology & Therapeutics · 2020 · 24 citations · Full text

Us Food, Pre-clinical Pharmacology, Adult Trials +19

Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration

Dionna J. Green, Xiaomei I. Liu, Tianyi Hua et al. · Clinical Pharmacology & Therapeutics · 2017 · 15 citations · Full text

Treatment Effect, Pharmacotherapy, Treatment Development +19