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

Systems Pharmacology to Predict Drug Toxicity: Integration Across Levels of Biological Organization

(2012) Jane P.F. Bai et al.   Annual Review of Pharmacology and Toxicology

Models of Physiology and Physiologically Based Models in Clinical Pharmacology

(2012) A J Atkinson et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

FDA Review Divisions: Performance Levels and the Impact on Drug Sponsors

(2012) C-P Milne et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Clinical Pharmacology and Orphan Drugs: An Informational Inventory 2006–2010

(2012) E D Bashaw et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

The Future of Orphan Drug Development

(2012) J Woodcock   CLINICAL PHARMACOLOGY & THERAPEUTICS

Evidence vs. Access: Can Twenty-First-Century Drug Regulation Refine the Tradeoffs?

(2012) J Woodcock   CLINICAL PHARMACOLOGY & THERAPEUTICS

Physiologically Based Pharmacokinetic (PBPK) Modeling in Children

(2012) J S Barrett et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval

(2012) H-G Eichler et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

(Q)SAR Modeling and Safety Assessment in Regulatory Review

(2012) N L Kruhlak et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Best Practice in the Use of Physiologically Based Pharmacokinetic Modeling and Simulation to Address Clinical Pharmacology Regulatory Questions

(2012) P Zhao et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

The Safety Risks of Innovation

(2012) Thomas J. Moore et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Diagnosing the decline in pharmaceutical R&D efficiency

(2012) Jack W. Scannell et al.   NATURE REVIEWS DRUG DISCOVERY

Bayesian Quantitative Disease–Drug–Trial Models for Parkinson’s Disease to Guide Early Drug Development

(2011) Joo Yeon Lee et al.   AAPS Journal

Utility of Physiologically Based Absorption Modeling in Implementing Quality by Design in Drug Development

(2011) Xinyuan Zhang et al.   AAPS Journal

Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions

(2011) Joo Yeon Lee et al.   CLINICAL PHARMACOKINETICS

Pharmacological Mechanism-Based Drug Safety Assessment and Prediction

(2011) D R Abernethy et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Pharmacogenomics and Clopidogrel

(2011) Steven E. Nissen   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Accelerated Approval of Oncology Products: The Food and Drug Administration Experience

(2011) John R. Johnson et al.   JNCI-Journal of the National Cancer Institute

Clinical pharmacology as a cornerstone of orphan drug development

(2011) Edward D. Bashaw et al.   NATURE REVIEWS DRUG DISCOVERY

Phase III and submission failures: 2007–2010

(2011) John Arrowsmith   NATURE REVIEWS DRUG DISCOVERY

Pharmacogenomics in the Assessment of Therapeutic Risks versus Benefits: Inside the United States Food and Drug Administration

(2011) Issam Zineh et al.   PHARMACOTHERAPY

Knowledge management for efficient quantitative analyses during regulatory reviews

(2011) Kevin Krudys et al.   Expert Review of Clinical Pharmacology

Applications of Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation During Regulatory Review

(2010) P Zhao et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Antiviral Information Management System (AIMS): A Prototype for Operational Innovation in Drug Development

(2010) Pravin R. Jadhav et al.   JOURNAL OF CLINICAL PHARMACOLOGY

A History of Biopharmaceutics in the Food and Drug Administration 1968–1993

(2009) Jerome Philip Skelly   AAPS Journal

Running a tightrope: Regulatory challenges in the development of antiretrovirals

(2009) Lisa K. Naeger et al.   ANTIVIRAL RESEARCH

Quantitative Disease, Drug, and Trial Models

(2008) Jogarao V.S. Gobburu et al.   Annual Review of Pharmacology and Toxicology

Is This the Drug or Dose for You?: Impact and Consideration of Ethnic Factors in Global Drug Development, Regulatory Review, and Clinical Practice

(2008) S-M Huang et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS