Benefit-Risk Assessment

TABLE OF CONTENTS

Volume 82, Issue 2 (August 2007)

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Contents

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Editorial

Benefit and Risk Assessment in Drug Development and Utilization: A Role for Clinical Pharmacology

P Honig

Clin Pharmacol Ther 82: 109-112; doi:10.1038/sj.clpt.6100277

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News & Views

Highlights

News and Views

Clin Pharmacol Ther 82: 114-115; doi:10.1038/sj.clpt.6100279

ASCPT News

ASCPT News

Clin Pharmacol Ther 82: 116-117; doi:10.1038/sj.clpt.6100280

Macroscopy

Role of the Centers for Education and Research on Therapeutics (CERTs) in Pharmacovigilance and Proper Use of Therapeutics

H H Tilson, L K Madre and R M Califf

Clin Pharmacol Ther 82: 118-121; doi:10.1038/sj.clpt.6100251

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Perspectives

Point/Counterpoint

Current Assessment of Risk–Benefit by Regulators: Is It Time to Introduce Decision Analyses?

D A Hughes, A M Bayoumi and M Pirmohamed

Clin Pharmacol Ther 82: 123-127; doi:10.1038/sj.clpt.6100240

Quantitative Decision Analysis: A Work in Progress

R Temple

Clin Pharmacol Ther 82: 127-130; doi:10.1038/sj.clpt.6100239

Commentaries

The Pharmaceutical Industry at Risk: How Excessive Government Regulation Stifles Innovation

R A Epstein

Clin Pharmacol Ther 82: 131-132; doi:10.1038/sj.clpt.6100257

Safety Monitoring of Drugs Granted Exclusivity Under the Best Pharmaceuticals for Children Act: What the FDA has Learned

L L Mathis and S Iyasu

Clin Pharmacol Ther 82: 133-134; doi:10.1038/sj.clpt.6100285

Pharmacology Education in Undergraduate and Graduate Medical Education in the United States

C Candler, M Ihnat and G Huang

Clin Pharmacol Ther 82: 134-137; doi:10.1038/sj.clpt.6100266

Pharmacometrics and the Transition to Model-Based Development

T H Grasela, C W Dement, O G Kolterman, M S Fineman, D M Grasela, P Honig, E J Antal, T D Bjornsson and E Loh

Clin Pharmacol Ther 82: 137-142; doi:10.1038/sj.clpt.6100270

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State of the Art

State of the Art

Developments in Post-marketing Comparative Effectiveness Research

S Schneeweiss

Clin Pharmacol Ther 82: 143-156; advance online publication, June 6, 2007; doi:10.1038/sj.clpt.6100249

Novel Statistical Tools for Monitoring the Safety of Marketed Drugs

J S Almenoff, E N Pattishall, T G Gibbs, W DuMouchel, S J W Evans and N Yuen

Clin Pharmacol Ther 82: 157-166; advance online publication, May 30, 2007; doi:10.1038/sj.clpt.6100258

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Research

Articles

Patient-reported Adverse Events Under Asthma Therapy: A Community Pharmacy-based Survey

L Laforest, E Van Ganse, G Devouassoux, L M Osman, G Bauguil and G Chamba

Clin Pharmacol Ther 82: 167-172; advance online publication, May 9, 2007; doi:10.1038/sj.clpt.6100224

An Evaluation of Computer-Aided Disproportionality Analysis for Post-Marketing Signal Detection

H P Lehman, J Chen, A L Gould, R Kassekert, P R Beninger, R Carney, M Goldberg, M A Goss, K Kidos, R G Sharrar, K Shields, A Sweet, B E Wiholm and P K Honig

Clin Pharmacol Ther 82: 173-180; advance online publication, May 16, 2007; doi:10.1038/sj.clpt.6100233

Inhibition of PKC beta by Ruboxistaurin Does Not Enhance the Acute Blood Pressure Response to Nitroglycerin

C Benson, M Seger and J Voelker

Clin Pharmacol Ther 82: 181-186; advance online publication, April 18, 2007; doi:10.1038/sj.clpt.6100210

Polymorphisms of ACE2 Gene are Associated With Essential Hypertension and Antihypertensive Effects of Captopril in Women

X Fan, Y Wang, K Sun, W Zhang, X Yang, S Wang, Y Zhen, J Wang, W Li, Y Han, T Liu, X Wang, J Chen, H Wu and R Hui and the study group for "Pharmacogenomic based Antihypertensive Drugs Selection, effects and side effects, in Rural Area Chinese”"

Clin Pharmacol Ther 82: 187-196; advance online publication, May 2, 2007; doi:10.1038/sj.clpt.6100214

Amodiaquine Metabolism is Impaired by Common Polymorphisms in CYP2C8: Implications for Malaria Treatment in Africa

S Parikh, J-B Ouedraogo, J A Goldstein, P J Rosenthal and D L Kroetz

Clin Pharmacol Ther 82: 197-203; advance online publication, March 14, 2007; doi:10.1038/sj.clpt.6100122

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Discovery & Development

Translation Medicine

The Challenge of Treating Biofilm-associated Bacterial Infections

J L del Pozo and R Patel

Clin Pharmacol Ther 82: 204-209; advance online publication, May 30, 2007; doi:10.1038/sj.clpt.6100247

Development

Preclinical Predictors of Clinical Safety: Opportunities for Improvement

F D Sistare and J J DeGeorge

Clin Pharmacol Ther 82: 210-214; advance online publication, May 16, 2007; doi:10.1038/sj.clpt.6100243

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Regulation & Use

Practice

Interethnic Differences in Drug Response: The Contribution of Genetic Variability in beta Adrenergic Receptor and Cytochrome P4502C9

M Muszkat

Clin Pharmacol Ther 82: 215-218; advance online publication, February 28, 2007; doi:10.1038/sj.clpt.6100142

Ethics

Balancing Justice and Autonomy in Clinical Research With Healthy Volunteers

N E Kass, R Myers, E J Fuchs, K A Carson and C Flexner

Clin Pharmacol Ther 82: 219-227; advance online publication, April 4, 2007; doi:10.1038/sj.clpt.6100192

Public Policy

Regulatory Considerations for Determining Postmarketing Study Commitments

R J Meyer

Clin Pharmacol Ther 82: 228-230; advance online publication, May 30, 2007; doi:10.1038/sj.clpt.6100238

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