Catalyzing the critical path initiative: FDA's progress in drug development activities

The International Serious Adverse Events Consortium

(2014) Arthur L. Holden et al.   NATURE REVIEWS DRUG DISCOVERY

Rechanneling the cardiac proarrhythmia safety paradigm: A meeting report from the Cardiac Safety Research Consortium

(2013) Philip T. Sager et al.   AMERICAN HEART JOURNAL

Performance of Pharmacovigilance Signal-Detection Algorithms for the FDA Adverse Event Reporting System

(2013) R Harpaz et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

The Utility of Modeling and Simulation in Drug Development and Regulatory Review

(2013) Shiew-Mei Huang et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Use of Partial Area under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release Formulations

(2012) Ethan M. Stier et al.   AAPS Journal

A Systematic Comparison of Cockcroft-Gault and Modification of Diet in Renal Disease Equations for Classification of Kidney Dysfunction and Dosage Adjustment

(2012) Eun Jung Park et al.   ANNALS OF PHARMACOTHERAPY

A Modeling and Simulation Approach to Characterize Methadone QT Prolongation Using Pooled Data From Five Clinical Trials in MMT Patients

(2012) J Florian et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

The UCSF-FDA TransPortal: A Public Drug Transporter Database

(2012) K M Morrissey et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Misclassification and discordance of measured blood pressure from patient’s true blood pressure in current clinical practice: a clinical trial simulation case study

(2012) Yuyan Jin et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions

(2011) Joo Yeon Lee et al.   CLINICAL PHARMACOKINETICS

A Likelihood Ratio Test Based Method for Signal Detection With Application to FDA’s Drug Safety Data

(2011) Lan Huang et al.   JOURNAL OF THE AMERICAN STATISTICAL ASSOCIATION

Tablet Splitting of a Narrow Therapeutic Index Drug: A Case with Levothyroxine Sodium

(2010) Rakhi B. Shah et al.   AAPS PHARMSCITECH

Rationale and design of the dual antiplatelet therapy study, a prospective, multicenter, randomized, double-blind trial to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet therapy in subjects undergoing percutaneous coronary intervention with either drug-eluting stent or bare metal stent placement for the treatment of coronary artery lesions

(2010) Laura Mauri et al.   AMERICAN HEART JOURNAL

Precompetitive Research: A New Prescription for Drug Development?

(2010) J Woodcock   CLINICAL PHARMACOLOGY & THERAPEUTICS