Clinical Pharmacology and Therapeutics - Table of Contents alert Volume 91 Issue 3

TABLE OF CONTENTS Volume 91, Issue 3 (March 2012) In this issue In This Issue Editorial News & Views Perspectives State of the Art Research Discovery & Development Regulation & Use Also new AOP Advertisement Myriad RBM's Comprehensive Protein Biomarker Solutions, helping turn biomarker studies into Biomarker Breakthroughs. From concept through clinical trial, Myriad RBM has the biomarkers, the platform and the expertise to guide your biomarker strategy. Click Here to learn more. Sign up for e-alerts Recommend to your library Web feed Subscribe Advertisement Clinpharmpod- Download and discover. Join us on clinpharmpod as we delve into the advances in the nature, action, efficacy, and evaluation of therapeutics in this cross-disciplinary field of experimental and clinical medicine featuring highlighted content from Clinical Pharmacology & Therapeutics.   In This Issue Top In This Issue Clin Pharmacol Ther 2012 91: 345; 10.1038/clpt.2012.2 Full Text Editorial Top EDITORIAL Regulatory Science and the Role of the Regulator in Biomedical Innovation P K Honig and S-M Huang Clin Pharmacol Ther 2012 91: 347-352; 10.1038/clpt.2011.352 Full Text Clinical Pharmacology & Therapeutics 2011: Year in Review S A Waldman and A Terzic Clin Pharmacol Ther 2012 91: 353-357; 10.1038/clpt.2011.353 Full Text News & Views Top Highlights Clin Pharmacol Ther 2012 91: 358-359; 10.1038/clpt.2012.1 Full Text ASCPT News Clin Pharmacol Ther 2012 91: 360-365; 10.1038/clpt.2011.354 Full Text Perspectives Top POINT/COUNTERPOINT Wrong Questions, Wrong Answers? Are We Getting the Drugs We Need? W L Lipworth, I H Kerridge and R O Day Clin Pharmacol Ther 2012 91: 367-369; 10.1038/clpt.2011.335 Full Text The Right Medicines—Just Not Enough of Them P K Honig Clin Pharmacol Ther 2012 91: 369-372; 10.1038/clpt.2011.332 Full Text COMMENTARIES Personalized Medicine: A Personal View U A Meyer Clin Pharmacol Ther 2012 91: 373-375; 10.1038/clpt.2011.238 Abstract | Full Text Transforming Regulatory Science 2012: Making a Difference J L Goodman Clin Pharmacol Ther 2012 91: 375-377; 10.1038/clpt.2011.329 Abstract | Full Text Evidence vs. Access: Can Twenty-First-Century Drug Regulation Refine the Tradeoffs? J Woodcock Clin Pharmacol Ther 2012 91: 378-380; 10.1038/clpt.2011.337 Abstract | Full Text The Critical Path Initiative: Leveraging Collaborations to Enhance Regulatory Science R A Barratt, S L Bowens, S K McCune, J N Johannessen and S Y Buckman Clin Pharmacol Ther 2012 91: 380-383; 10.1038/clpt.2011.318 Abstract | Full Text Current and Future State of FDA-CMS Parallel Reviews D A Messner and S R Tunis Clin Pharmacol Ther 2012 91: 383-385; 10.1038/clpt.2011.350 Abstract | Full Text Heterotropic Effects on Drug-Metabolizing Enzyme Activities: In Vitro Curiosity Emerges as a Clinically Meaningful Phenomenon (Perhaps?) R S Obach Clin Pharmacol Ther 2012 91: 385-387; 10.1038/clpt.2011.182 Abstract | Full Text Pharmacogenomic Testing: Knowing More, Doing Better J E Lunshof and D Gurwitz Clin Pharmacol Ther 2012 91: 387-389; 10.1038/clpt.2011.339 Abstract | Full Text CONFERENCE PROCEEDINGS Is It Possible for FDA Regulatory Scientists and Industry Scientists to Work Together? R L Woosley Clin Pharmacol Ther 2012 91: 390-392; 10.1038/clpt.2011.304 Abstract | Full Text State of the Art Top STATE OF THE ART FDA Review Divisions: Performance Levels and the Impact on Drug Sponsors C-P Milne and K I Kaitin Clin Pharmacol Ther 2012 91: 393-404; advance online publication, February 15, 2012; 10.1038/clpt.2011.338 Abstract | Full Text The State of the Art in the Development of Biosimilars Mark McCamish and Gillian Woollett Clin Pharmacol Ther 2012 91: 405-417; advance online publication, February 8, 2012; 10.1038/clpt.2011.343 Abstract | Full Text The Innovative Medicines Initiative: A European Response to the Innovation Challenge M Goldman Clin Pharmacol Ther 2012 91: 418-425; advance online publication, February 8, 2012; 10.1038/clpt.2011.321 Abstract | Full Text Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval H-G Eichler, K Oye, L G Baird, E Abadie, J Brown, C L Drum, J Ferguson, S Garner, P Honig, M Hukkelhoven, J C W Lim, R Lim, M M Lumpkin, G Neil, B O'Rourke, E Pezalla, D Shoda, V Seyfert-Margolis, E V Sigal, J Sobotka, D Tan, T F Unger and G Hirsch Clin Pharmacol Ther 2012 91: 426-437; advance online publication, February 15, 2012; 10.1038/clpt.2011.345 Abstract | Full Text Research Top REPORT Effect of the Market Withdrawal of Carisoprodol on Use of Other Prescribed Drugs With Abuse Potential J G Bramness, K Furu, S Skurtveit and A Engeland Clin Pharmacol Ther 2012 91: 438-441; advance online publication, February 8, 2012; 10.1038/clpt.2011.250 Abstract | Full Text ARTICLES Evidence of CYP3A Allosterism In Vivo: Analysis of Interaction Between Fluconazole and Midazolam J Yang, W M Atkins, N  Isoherranen, M F Paine and K E Thummel Clin Pharmacol Ther 2012 91: 442-449; advance online publication, November 2, 2011; 10.1038/clpt.2011.178 Abstract | Full Text Adoption of Pharmacogenomic Testing by US Physicians: Results of a Nationwide Survey E J Stanek, C L Sanders, K A Johansen Taber, M Khalid, A Patel, R R Verbrugge, B C Agatep, R E Aubert, R S Epstein and F W Frueh Clin Pharmacol Ther 2012 91: 450-458; advance online publication, January 25, 2012; 10.1038/clpt.2011.306 Abstract | Full Text A Randomized, Placebo-Controlled Study of the Effects of Telcagepant on Exercise Time in Patients With Stable Angina B R Chaitman, A P Ho, M O Behm, J F Rowe, J S Palcza, T Laethem, I Heirman, D L Panebianco, Z Kobalava, S Y Martsevich, A L Free, N Bittar, S G Chrysant, T W Ho, J A Chodakewitz, M G Murphy and R L Blanchard Clin Pharmacol Ther 2012 91: 459-466; advance online publication, January 25, 2012; 10.1038/clpt.2011.246 Abstract | Full Text Detection of Adverse Drug Reaction Signals Using an Electronic Health Records Database: Comparison of the Laboratory Extreme Abnormality Ratio (CLEAR) Algorithm D Yoon, M Y Park, N K Choi, B J Park, J H Kim and R W Park Clin Pharmacol Ther 2012 91: 467-474; advance online publication, January 11, 2012; 10.1038/clpt.2011.248 Abstract | Full Text Induction of CYP2C19 and CYP3A Activity Following Repeated Administration of Efavirenz in Healthy Volunteers V Michaud, E Ogburn, N Thong, A O Aregbe, T C Quigg, D A Flockhart and Z Desta Clin Pharmacol Ther 2012 91: 475-482; advance online publication, February 8, 2012; 10.1038/clpt.2011.249 Abstract | Full Text Steady-State Carbamazepine Pharmacokinetics Following Oral and Stable-Labeled Intravenous Administration in Epilepsy Patients: Effects of Race and Sex S E Marino, A K Birnbaum, I E Leppik, J M Conway, L C Musib, R C Brundage, R E Ramsay, P B Pennell, J R White, C R Gross, J O Rarick, U Mishra and J C Cloyd Clin Pharmacol Ther 2012 91: 483-488; advance online publication, January 25, 2012; 10.1038/clpt.2011.251 Abstract | Full Text Oral Flurbiprofen Metabolic Ratio Assessment Using a Single-Point Dried Blood Spot Y Daali, C Samer, J Déglon, A Thomas, J Chabert, M Rebsamen, C Staub, P Dayer and J Desmeules Clin Pharmacol Ther 2012 91: 489-496; advance online publication, January 11, 2012; 10.1038/clpt.2011.247 Abstract | Full Text Population Pharmacokinetics and Pharmacodynamics of Piperaquine in Children With Uncomplicated Falciparum Malaria J Tarning, I Zongo, F A Somé, N Rouamba, S Parikh, P J Rosenthal, W Hanpithakpong, N Jongrak, N P J Day, N J White, F Nosten, J-B Ouedraogo and N Lindegardh Clin Pharmacol Ther 2012 91: 497-505; advance online publication, January 18, 2012; 10.1038/clpt.2011.254 Abstract | Full Text Impact of Efavirenz on Intestinal Metabolism and Transport: Insights From an Interaction Study With Ezetimibe in Healthy Volunteers S Oswald, H E Meyer zu Schwabedissen, A Nassif, C Modess, Z Desta, E T Ogburn, J Mostertz, M Keiser, J Jia, A Hubeny, A Ulrich, D Runge, M Marinova, D Lütjohann, H K Kroemer and W Siegmund Clin Pharmacol Ther 2012 91: 506-513; advance online publication, February 1, 2012; 10.1038/clpt.2011.255 Abstract | Full Text Shift From Surrogate End Point to Outcome Trials: Implications for Cardiovascular Safety Assessment in Development Programs for Antidiabetic Drugs J F Marcinak, P Viswanathan, V Arora, L E Roebel, T R Strack and E Leifke Clin Pharmacol Ther 2012 91: 514-520; advance online publication, November 23, 2011; 10.1038/clpt.2011.257 Abstract | Full Text High-Risk Prescribing and Incidence of Frailty Among Older Community-Dwelling Men D Gnjidic, S N Hilmer, F M Blyth, V Naganathan, R G Cumming, D J Handelsman, A J McLachlan, D R Abernethy, E Banks and D G Le Couteur Clin Pharmacol Ther 2012 91: 521-528; advance online publication, February 1, 2012; 10.1038/clpt.2011.258 Abstract | Full Text Discovery & Development Top DISCOVERY (Q)SAR Modeling and Safety Assessment in Regulatory Review N L Kruhlak, R D Benz, H Zhou and T J Colatsky Clin Pharmacol Ther 2012 91: 529-534; advance online publication, January 18, 2012; 10.1038/clpt.2011.300 Abstract | Full Text DEVELOPMENT Impediments to Clinical Research in the United States J M Kramer, P B Smith and R M Califf Clin Pharmacol Ther 2012 91: 535-541; advance online publication, February 8, 2012; 10.1038/clpt.2011.341 Abstract | Full Text The Role of Physiologically Based Pharmacokinetic Modeling in Regulatory Review S-M Huang and M Rowland Clin Pharmacol Ther 2012 91: 542-549; advance online publication, February 8, 2012; 10.1038/clpt.2011.320 Abstract | Full Text The Prevention and Treatment of Missing Data in Clinical Trials: An FDA Perspective on the Importance of Dealing With It R T O'Neill and R Temple Clin Pharmacol Ther 2012 91: 550-554; advance online publication, February 8, 2012; 10.1038/clpt.2011.340 Abstract | Full Text Regulation & Use Top PRACTICE Regulatory Innovation in Postmarketing Risk Assessment and Management J A Staffa and G J Dal Pan Clin Pharmacol Ther 2012 91: 555-557; advance online publication, February 1, 2012; 10.1038/clpt.2011.289 Abstract | Full Text Advertisement Ensure your access If you are unable to access the articles in thisalert, your library may not subscribe to this journal. 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