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Shift From Surrogate End Point to Outcome Trials: Implications for Cardiovascular Safety Assessment in Development Programs for Antidiabetic Drugs.
- Published in:
- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 514, doi. 10.1038/clpt.2011.257
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- Publication type:
- Article
Impact of Efavirenz on Intestinal Metabolism and Transport: Insights From an Interaction Study With Ezetimibe in Healthy Volunteers.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 506, doi. 10.1038/clpt.2011.255
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- Article
Personalized Medicine: A Personal View.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 373, doi. 10.1038/clpt.2011.238
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- Article
Oral Flurbiprofen Metabolic Ratio Assessment Using a Single-Point Dried Blood Spot.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 489, doi. 10.1038/clpt.2011.247
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- Publication type:
- Article
Detection of Adverse Drug Reaction Signals Using an Electronic Health Records Database: Comparison of the Laboratory Extreme Abnormality Ratio (CLEAR) Algorithm.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 467, doi. 10.1038/clpt.2011.248
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- Publication type:
- Article
Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 426, doi. 10.1038/clpt.2011.345
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- Publication type:
- Article
Transforming Regulatory Science 2012: Making a Difference.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 375, doi. 10.1038/clpt.2011.329
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- Publication type:
- Article
High-Risk Prescribing and Incidence of Frailty Among Older Community-Dwelling Men.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 521, doi. 10.1038/clpt.2011.258
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- Publication type:
- Article
(Q)SAR Modeling and Safety Assessment in Regulatory Review.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 529, doi. 10.1038/clpt.2011.300
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- Publication type:
- Article
Effect of the Market Withdrawal of Carisoprodol on Use of Other Prescribed Drugs With Abuse Potential.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 438, doi. 10.1038/clpt.2011.250
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- Publication type:
- Article
Current and Future State of FDA-CMS Parallel Reviews.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 383, doi. 10.1038/clpt.2011.350
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- Publication type:
- Article
Impediments to Clinical Research in the United States.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 535, doi. 10.1038/clpt.2011.341
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- Publication type:
- Article
Heterotropic Effects on Drug-Metabolizing Enzyme Activities: In Vitro Curiosity Emerges as a Clinically Meaningful Phenomenon (Perhaps?).
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 385, doi. 10.1038/clpt.2011.182
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- Article
Wrong Questions, Wrong Answers? Are We Getting the Drugs We Need?
- Published in:
- 2012
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- Publication type:
- Opinion
Evidence of CYP3A Allosterism In Vivo: Analysis of Interaction Between Fluconazole and Midazolam.
- Published in:
- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 442, doi. 10.1038/clpt.2011.178
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- Publication type:
- Article
Population Pharmacokinetics and Pharmacodynamics of Piperaquine in Children With Uncomplicated Falciparum Malaria.
- Published in:
- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 497, doi. 10.1038/clpt.2011.254
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- Publication type:
- Article
Highlights.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 358, doi. 10.1038/clpt.2012.1
- Publication type:
- Article
Evidence vs. Access: Can Twenty-First-Century Drug Regulation Refine the Tradeoffs?
- Published in:
- 2012
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- Publication type:
- Opinion
Regulatory Innovation in Postmarketing Risk Assessment and Management.
- Published in:
- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 555, doi. 10.1038/clpt.2011.289
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- Publication type:
- Article
The Prevention and Treatment of Missing Data in Clinical Trials: An FDA Perspective on the Importance of Dealing With It.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 550, doi. 10.1038/clpt.2011.340
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- Publication type:
- Article
Steady-State Carbamazepine Pharmacokinetics Following Oral and Stable-Labeled Intravenous Administration in Epilepsy Patients: Effects of Race and Sex.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 483, doi. 10.1038/clpt.2011.251
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- Publication type:
- Article
The Role of Physiologically Based Pharmacokinetic Modeling in Regulatory Review.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 542, doi. 10.1038/clpt.2011.320
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- Publication type:
- Article
The Right Medicines-Just Not Enough of Them.
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- 2012
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- Publication type:
- Opinion
The State of the Art in the Development of Biosimilars.
- Published in:
- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 405, doi. 10.1038/clpt.2011.343
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- Publication type:
- Article
Is It Possible for FDA Regulatory Scientists and Industry Scientists to Work Together?
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 390, doi. 10.1038/clpt.2011.304
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- Publication type:
- Article
The Critical Path Initiative: Leveraging Collaborations to Enhance Regulatory Science.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 380, doi. 10.1038/clpt.2011.318
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- Publication type:
- Article
Induction of CYP2C19 and CYP3A Activity Following Repeated Administration of Efavirenz in Healthy Volunteers.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 475, doi. 10.1038/clpt.2011.249
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- Publication type:
- Article
In This Issue.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 345, doi. 10.1038/clpt.2012.2
- Publication type:
- Article
The Innovative Medicines Initiative: A European Response to the Innovation Challenge.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 418, doi. 10.1038/clpt.2011.321
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- Publication type:
- Article
A Randomized, Placebo-Controlled Study of the Effects of Telcagepant on Exercise Time in Patients With Stable Angina.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 459, doi. 10.1038/clpt.2011.246
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- Publication type:
- Article
Regulatory Science and the Role of the Regulator in Biomedical Innovation.
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- 2012
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- Publication type:
- Editorial
Pharmacogenomic Testing: Knowing More, Doing Better.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 387, doi. 10.1038/clpt.2011.339
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- Publication type:
- Article
FDA Review Divisions: Performance Levels and the Impact on Drug Sponsors.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 393, doi. 10.1038/clpt.2011.338
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- Publication type:
- Article
Clinical Pharmacology & Therapeutics 2011: Year in Review.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 353, doi. 10.1038/clpt.2011.353
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- Publication type:
- Article
ASCPT News.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 360, doi. 10.1038/clpt.2011.354
- Publication type:
- Article
Adoption of Pharmacogenomic Testing by US Physicians: Results of a Nationwide Survey.
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- Clinical Pharmacology & Therapeutics, 2012, v. 91, n. 3, p. 450, doi. 10.1038/clpt.2011.306
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- Publication type:
- Article