Drug Safety and Pharmacovigilance

TABLE OF CONTENTS

Volume 85, Issue 3 (March 2009)

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In This Issue

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Editorial

Editorial

Drug Safety and the Role of Clinical Pharmacology in the Safe Use of Therapeutics

PK Honig

Clin Pharmacol Ther 85: 225-228; doi:10.1038/clpt.2008.275

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News & Views

Highlights

Highlights

Clin Pharmacol Ther 85: 230-231; doi:10.1038/clpt.2008.298

ASCPT News

ASCPT News

Clin Pharmacol Ther 85: 232-233; doi:10.1038/clpt.2008.300

Books

Starting With Serotonin: How a High-Rolling Father of Drug Discovery Repeatedly Beat the Odds

Reviewed by G Pickering

Clin Pharmacol Ther 85: 234-235; doi:10.1038/clpt.2008.248

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Perspectives

Opinion

Adding a Medicine to the WHO Model List of Essential Medicines

SP Kishore and BJ Herbstman

Clin Pharmacol Ther 85: 237-239; doi:10.1038/clpt.2008.258

Model-Based Benefit–Risk Assessment: Can Archimedes Help?

R Krishna

Clin Pharmacol Ther 85: 239-240; doi:10.1038/clpt.2008.240

Conference Proceedings

Measuring Benefit and Balancing Risk: Strategies for the Benefit–Risk Assessment of New Medicines in a Risk-Averse Environment

S Walker, N McAuslane, L Liberti and S Salek

Clin Pharmacol Ther 85: 241-246; doi:10.1038/clpt.2008.277

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State of the Art

State of the Art

Safety Assessment and Dose Selection for First-in-Human Clinical Trials With Immunomodulatory Monoclonal Antibodies

PY Muller and FR Brennan

Clin Pharmacol Ther 85: 247-258; advance online publication, January 28, 2009; doi:10.1038/clpt.2008.273

Data-Driven Methods to Discover Molecular Determinants of Serious Adverse Drug Events FREE

AP Chiang and AJ Butte

Clin Pharmacol Ther 85: 259-268; advance online publication, January 28, 2009; doi:10.1038/clpt.2008.274

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Research

Reports

Impact of the CYP2D6 Genotype on the Clinical Effects of Metoprolol: A Prospective Longitudinal Study

T Rau, H Wuttke, LM Michels, U Werner, K Bergmann, M Kreft, MF Fromm and T Eschenhagen

Clin Pharmacol Ther 85: 269-272; advance online publication, November 26, 2008; doi:10.1038/clpt.2008.218

Interindividual Variation in the Pharmacokinetics of Delta9-Tetrahydrocannabinol as Related to Genetic Polymorphisms in CYP2C9

C Sachse-Seeboth, J Pfeil, D Sehrt, I Meineke, M Tzvetkov, E Bruns, W Poser, SV Vormfelde and J Brockmöller

Clin Pharmacol Ther 85: 273-276; advance online publication, November 12, 2008; doi:10.1038/clpt.2008.213

Articles

The Use of a Clinical Utility Index to Compare Insomnia Compounds: A Quantitative Basis for Benefit–Risk Assessment

D Ouellet, J Werth, N Parekh, D Feltner, B McCarthy and RL Lalonde

Clin Pharmacol Ther 85: 277-282; advance online publication, December 10, 2008; doi:10.1038/clpt.2008.235

Are Migraineurs at Increased Risk of Adverse Drug Responses?: A Meta-Analytic Comparison of Topiramate-Related Adverse Drug Reactions in Epilepsy and Migraine

J Luykx, M Mason, MD Ferrari and J Carpay

Clin Pharmacol Ther 85: 283-288; advance online publication, November 5, 2008; doi:10.1038/clpt.2008.203

High Levels of P-Glycoprotein Activity in Human Lymphocytes in the First 6 Months of Life

C Giraud, X Declèves, JY Perrot, S Manceau, E Pannier, G Firtion, JP Morini, H Chappuy, F Batteux, S Chouzenoux, JM Scherrmann, S Blanche and JM Tréluyer

Clin Pharmacol Ther 85: 289-295; advance online publication, November 26, 2008; doi:10.1038/clpt.2008.221

Pharmacogenetics of Modafinil After Sleep Loss: Catechol-O-Methyltransferase Genotype Modulates Waking Functions But Not Recovery Sleep

S Bodenmann, S Xu, UFO Luhmann, M Arand, W Berger, HH Jung and HP Landolt

Clin Pharmacol Ther 85: 296-304; advance online publication, November 26, 2008; doi:10.1038/clpt.2008.222

Assessment of the Impact of Renal Impairment on Systemic Exposure of New Molecular Entities: Evaluation of Recent New Drug Applications

Y Zhang, L Zhang, S Abraham, S Apparaju, T-C Wu, JM Strong, S Xiao, AJ Atkinson Jr, KE Thummel, JS Leeder, C Lee, GJ Burckart, LJ Lesko and S-M Huang

Clin Pharmacol Ther 85: 305-311; advance online publication, November 19, 2008; doi:10.1038/clpt.2008.208

The CYP3A4*18 Genotype in the Cytochrome P450 3A4 Gene, a Rapid Metabolizer of Sex Steroids, Is Associated With Low Bone Mineral Density

YS Kang, SY Park, CH Yim, HS Kwak, P Gajendrarao, N Krishnamoorthy, S-C Yun, KW Lee and KO Han

Clin Pharmacol Ther 85: 312-318; advance online publication, November 19, 2008; doi:10.1038/clpt.2008.215

Irreversible CYP3A Inhibition Accompanied by Plasma Protein–Binding Displacement: A Comparative Analysis in Subjects With Normal and Impaired Liver Function

R Orlando, S De Martin, P Pegoraro, L Quintieri and P Palatini

Clin Pharmacol Ther 85: 319-326; advance online publication, November 19, 2008; doi:10.1038/clpt.2008.216

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Discovery & Development

Translational Medicine

Translational Toxicology and the Work of the Predictive Safety Testing Consortium

WB Mattes and EG Walker

Clin Pharmacol Ther 85: 327-330; advance online publication, January 21, 2009; doi:10.1038/clpt.2008.270

Development

Monitoring for Hepatotoxicity: What Is the Predictive Value of Liver "Function" Tests?

JR Senior

Clin Pharmacol Ther 85: 331-334; advance online publication, January 7, 2009; doi:10.1038/clpt.2008.262

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Regulation and Use

Public Policy

Perspectives on Early Communication of Drug Risks to the Public

PJ Seligman and SF Osborne

Clin Pharmacol Ther 85: 335-339; advance online publication, January 21, 2009; doi:10.1038/clpt.2008.272

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Corrigendum

Corrigendum

CORRIGENDUM: Government Support for Abstinence-Only-Until-Marriage Education FREE

Clin Pharmacol Ther 85: 340; doi:10.1038/clpt.2008.268

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