TABLE OF CONTENTS

Volume 86, Issue 1 (July 2009)

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In This Issue

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Editorial

Editorial

Biomarkers: Principles, Policies, and Practice

JA Wagner

Clin Pharmacol Ther 86: 3-7; doi:10.1038/clpt.2009.77

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News & Views

Highlights

Highlights

Clin Pharmacol Ther 86: 8-9; doi:10.1038/clpt.2009.91

ASCPT News

ASCPT News

Clin Pharmacol Ther 86: 10-11; doi:10.1038/clpt.2009.84

Macroscopy

Chutes and Ladders on the Critical Path:Comparative Effectiveness, Product Value, and the Use of Biomarkers in Drug Development

J Woodcock

Clin Pharmacol Ther 86: 12-14; doi:10.1038/clpt.2009.33

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Perspectives

Point/Counterpoint

Direct-to-Consumer Genetic Testing: Failure Is Not an Option

RB Altman

Clin Pharmacol Ther 86: 15-17; doi:10.1038/clpt.2009.63

See also: Point/Counterpoint by Schickedanz & Herdman
Direct-to-Consumer Genetic Testing: The Need to Get Retail Genomics Right

AD Schickedanz and RC Herdman

Clin Pharmacol Ther 86: 17-20; doi:10.1038/clpt.2009.56

See also: Point/Counterpoint by Altman

Opinion

Personalized Medicine: A Perk of Privilege?

JJ Griggs

Clin Pharmacol Ther 86: 21-23; doi:10.1038/clpt.2009.75

Educating for Personalized Medicine: A Perspective From Oncology

DR Parkinson and J Ziegler

Clin Pharmacol Ther 86: 23-25; doi:10.1038/clpt.2009.76

Commentaries

Biomarkers in Clinical Drug Development

JVS Gobburu

Clin Pharmacol Ther 86: 26-27; doi:10.1038/clpt.2009.57

See also: State of the Art by Lathia et al.
Addressing the Challenges of the Clinical Application of Pharmacogenetic Testing

ON Ikediobi, J Shin, RL Nussbaum and KA Phillips and the UCSF Center for Translational and Policy Research on Personalized Medicine (group authors: JM Walsh, U Ladabaum and D Marshall)

Clin Pharmacol Ther 86: 28-31; doi:10.1038/clpt.2009.30

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State of the Art

State of the Art

The Value, Qualification, and Regulatory Use of Surrogate End Points in Drug Development

CD Lathia, D Amakye, W Dai, C Girman, S Madani, J Mayne, P MacCarthy, P Pertel, L Seman, A Stoch, P Tarantino, C Webster, S Williams and JA Wagner

Clin Pharmacol Ther 86: 32-43; advance online publication, May 27, 2009; doi:10.1038/clpt.2009.69

See also: Commentary by Gobburu
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Research

Reports

Efficacy of 3,4-Diaminopyridine and Pyridostigmine in the Treatment of Lambert–Eaton Myasthenic Syndrome: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study

PW Wirtz, JJ Verschuuren, JG van Dijk, ML de Kam, RC Schoemaker, JGC van Hasselt, MJ Titulaer, UR Tjaden, J den Hartigh and JMA van Gerven

Clin Pharmacol Ther 86: 44-48; advance online publication, April 8, 2009; doi:10.1038/clpt.2009.35

Bronchodilatory Effect of the PPAR-bold gamma Agonist Rosiglitazone in Smokers With Asthma

M Spears, I Donnelly, L Jolly, M Brannigan, K Ito, C McSharry, J Lafferty, R Chaudhuri, G Braganza, P Bareille, L Sweeney, IM Adcock, PJ Barnes, S Wood and NC Thomson

Clin Pharmacol Ther 86: 49-53; advance online publication, April 8, 2009; doi:10.1038/clpt.2009.41

Articles

Relative Impact of Genotype and Enzyme Induction on the Metabolic Capacity of CYP2C9 in Healthy Volunteers

SV Vormfelde, J Brockmöller, S Bauer, P Herchenhein, J Kuon, I Meineke, I Roots and J Kirchheiner

Clin Pharmacol Ther 86: 54-61; advance online publication, April 15, 2009; doi:10.1038/clpt.2009.40

Comparison of Dose-Finding Designs for Narrow-Therapeutic-Index Drugs: Concentration-Controlled vs. Dose-Controlled Trials

R Lledó-García, S Hennig and MO Karlsson

Clin Pharmacol Ther 86: 62-69; advance online publication, April 1, 2009; doi:10.1038/clpt.2009.23

See also: Article by Lledó-García et al.
The Influence of Underlying Assumptions on Evaluating the Relative Merits of Concentration-Controlled and Dose-Controlled Trials

R Lledó-García, S Hennig and MO Karlsson

Clin Pharmacol Ther 86: 70-76; advance online publication, March 11, 2009; doi:10.1038/clpt.2009.24

See also: Article by Lledó-García et al.
Mechanistic Modeling of a Magnetic Marker Monitoring Study Linking Gastrointestinal Tablet Transit, In Vivo Drug Release, and Pharmacokinetics

M Bergstrand, E Söderlind, W Weitschies and MO Karlsson

Clin Pharmacol Ther 86: 77-83; advance online publication, April 22, 2009; doi:10.1038/clpt.2009.43

Modeling and Simulation of the Time Course of Asenapine Exposure Response and Dropout Patterns in Acute Schizophrenia

LE Friberg, R de Greef, T Kerbusch and MO Karlsson

Clin Pharmacol Ther 86: 84-91; advance online publication, April 22, 2009; doi:10.1038/clpt.2009.44

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Discovery & Development

Discovery

Biomarker Discovery: Identification of a Growth Factor Gene Signature

A Loboda, M Nebozhyn, C Cheng, R Vessey, P Huang, H Dai and JW Watters

Clin Pharmacol Ther 86: 92-96; advance online publication, April 22, 2009; doi:10.1038/clpt.2009.48

Translational Medicine

I-SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy

AD Barker, CC Sigman, GJ Kelloff, NM Hylton, DA Berry and LJ Esserman

Clin Pharmacol Ther 86: 97-100; advance online publication, May 13, 2009; doi:10.1038/clpt.2009.68

Development

QT as a Safety Biomarker in Drug Development

DJ Whellan, CL Green, JP Piccini and MW Krucoff

Clin Pharmacol Ther 86: 101-104; advance online publication, May 27, 2009; doi:10.1038/clpt.2009.70

The Clinical Utility Index as a Practical Multiattribute Approach to Drug Development Decisions

B Poland, FL Hodge, A Khan, RT Clemen, JA Wagner, K Dykstra and R Krishna

Clin Pharmacol Ther 86: 105-108; advance online publication, May 20, 2009; doi:10.1038/clpt.2009.71

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Regulation & Use

Practice

Clinically Available Pharmacogenomics Tests

DA Flockhart, T Skaar, DS Berlin, TE Klein and AT Nguyen

Clin Pharmacol Ther 86: 109-113; advance online publication, April 15, 2009; doi:10.1038/clpt.2009.39

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Corrigendum

Corrigendum

CORRIGENDUM: Abstract PII-56: Integrated Modeling of PANSS and Dropout Analysis in Patients With Acute Schizophrenia FREE

Clin Pharmacol Ther 86: 114; doi:10.1038/clpt.2009.46

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