A. Bhattaram

发表

Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling

Justin C. Earp, Jiang Liu, V. Sinha, 2016, Drug Metabolism and Disposition.

CYP2D6 genotype information to guide pimozide treatment in adult and pediatric patients: basis for the U.S. Food and Drug Administration's new dosing recommendations.

I. Zineh, J. Gobburu, M. Pacanowski, 2012, The Journal of clinical psychiatry.

Precompetitive Data Sharing as a Catalyst to Address Unmet Needs in Parkinson’s Disease

Arthur W. Toga, Max A. Little, Margaret Sutherland, 2015, Journal of Parkinson's disease.

CENTER FOR DRUG EVALUATION AND RESEARCH

M. Bewernitz, A. Men, A. Bhattaram, 2007 .

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

Yaning Wang, Lawrence J Lesko, Rajanikanth Madabushi, 2008, Journal of clinical pharmacology.

Model‐Informed Drug Development in Pediatric Dose Selection

Justin C. Earp, Jiang Liu, Xinyuan Zhang, 2021, Journal of clinical pharmacology.

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

Hao Zhu, Chao Liu, Yaning Wang, 2019, Journal of clinical pharmacology.

Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant.

Sue-Jane Wang, I. Zineh, E. Unger, 2011, The Journal of clinical psychiatry.

Extrapolation of Efficacy from Adults to Pediatric Patients of Drugs for Treatment of Partial Onset Seizures: A Regulatory Perspective

B. Dunn, R. Uppoor, E. Bastings, 2022, Clinical pharmacology and therapeutics.

Knowledge management for efficient quantitative analyses during regulatory reviews

Yaning Wang, Christoffer Tornoe, Lauren Neal, 2011, Expert review of clinical pharmacology.

Model‐Informed Approaches to Support Drug Development for Patients With Obesity: A Regulatory Perspective

Justin C. Earp, Y. Bi, Fang Li, 2023, Journal of clinical pharmacology.

Special Section on Pediatric Drug Disposition and Pharmacokinetics Role of Quantitative Clinical Pharmacology in Pediatric Approval and Labeling

Justin C. Earp, Jiang Liu, D. Tibboel, 2016 .