Commentaries:

Raymond L. Woosley

They Are From the Government and They Really Are Here to Help You
J Clin Pharmacol 2008 48: 142. [Full Text] [PDF]  

Donald R. Stanski and John J. Orloff

Communicating With the FDA: The "Third Rail" of a New Model for Drug Development
J Clin Pharmacol 2008 48: 144. [Full Text] [PDF]  

Regulatory Science:

Yaning Wang, A. Venkatesh Bhattaram, Pravin R. Jadhav, Lawrence J. Lesko, Rajanikanth Madabushi, J. Robert Powell, Wei Qiu, He Sun, Dong S. Yim, Jenny J. Zheng, and Jogarao V. S. Gobburu

Leveraging Prior Quantitative Knowledge to Guide Drug Development Decisions and Regulatory Science Recommendations: Impact of FDA Pharmacometrics During 2004-2006
J Clin Pharmacol 2008 48: 146. [Abstract] [Full Text] [PDF]  

Pharmacokinetics:

Kristin L. Bigos, Bruce G. Pollock, Kim C. Coley, Del D. Miller, Stephen R. Marder, Manickam Aravagiri, Margaret A. Kirshner, Lon S. Schneider, and Robert R. Bies

Sex, Race, and Smoking Impact Olanzapine Exposure
J Clin Pharmacol 2008 48: 157. [Abstract] [Full Text] [PDF]  

Tausif Ahmed, Pradeep Sharma, Anirudh Gautam, Brijesh Varshney, Monica Kothari, Sanjeev Ganguly, Joerg J. Moehrle, Jyoti Paliwal, Nilanjan Saha, and Vijay Batra

Safety, Tolerability, and Single- and Multiple-Dose Pharmacokinetics of Piperaquine Phosphate in Healthy Subjects
J Clin Pharmacol 2008 48: 166. [Abstract] [Full Text] [PDF]  

Ying-Jun Cao, Brian Caffo, Leena Choi, Christine L. Radebaugh, Edward J. Fuchs, and Craig W. Hendrix

Noninvasive Quantitation of Drug Concentration in Prostate and Seminal Vesicles: Improvement and Validation With Desipramine and Aspirin
J Clin Pharmacol 2008 48: 176. [Abstract] [Full Text] [PDF]  

Jun Suzuki, Freerk Broeyer, Adam Cohen, Masato Takebe, Jacobus Burggraaf, and Yutaka Mizushima

Pharmacokinetics of PC-SOD, a Lecithinized Recombinant Superoxide Dismutase, After Single- and Multiple-Dose Administration to Healthy Japanese and Caucasian Volunteers
J Clin Pharmacol 2008 48: 184. [Abstract] [Full Text] [PDF]  

Kenneth C. Lasseter, Laura Shaughnessy, David Cummings, John C. Pezzullo, William Wargin, Rene Gagnon, Jesus Oliva, and Gordana Kosutic

Ghrelin Agonist (TZP-101): Safety, Pharmacokinetics and Pharmacodynamic Evaluation in Healthy Volunteers: A Phase I, First-in-Human Study
J Clin Pharmacol 2008 48: 193. [Abstract] [Full Text] [PDF]  

Pharmacokinetics/Special Populations:

Kunihiko Ohnishi, Atsuhiro Kawaguchi, Shunji Nakajima, Hiroyuki Mori, and Takahiro Ueshima

A Comparative Pharmacokinetic Study of Recombinant Human Serum Albumin With Plasma-derived Human Serum Albumin in Patients With Liver Cirrhosis
J Clin Pharmacol 2008 48: 203. [Abstract] [Full Text] [PDF]  

Drug Interactions:

Marian Iwamoto, Kelem Kassahun, Matthew D. Troyer, William D. Hanley, Ping Lu, Alisha Rhoton, Amelia S. Petry, Kalyan Ghosh, Eric Mangin, Emanuel P. DeNoia, Larissa A. Wenning, Julie A. Stone, Keith M. Gottesdiener, and John A. Wagner

Lack of a Pharmacokinetic Effect of Raltegravir on Midazolam: In Vitro/In Vivo Correlation
J Clin Pharmacol 2008 48: 209. [Abstract] [Full Text] [PDF]  

Clinical Studies:

Matthew M. Hutmacher, Sunny Chapel, Marilyn A. Agin, Joseph C. Fleishaker, and Richard L. Lalonde

Performance Characteristics for Some Typical QT Study Designs Under the ICH E-14 Guidance
J Clin Pharmacol 2008 48: 215. [Abstract] [Full Text] [PDF]  

Therapeutic Review:

L. Michael Prisant

Nebivolol: Pharmacologic Profile of an Ultraselective, Vasodilatory β₁-Blocker
J Clin Pharmacol 2008 48: 225. [Abstract] [Full Text] [PDF]  

Brief Reports/Pharmacokinetics:

Sophia L. Markantonis, Eleftheria Tsakalozou, Anteia Paraskeva, Chryssoula Staikou, and Argyro Fassoulaki

Melatonin Pharmacokinetics in Premenopausal and Postmenopausal Healthy Female Volunteers
J Clin Pharmacol 2008 48: 240. [Full Text] [PDF]  

Gilbert Lefèvre, Françoise Pommier, Greg Sedek, Mark Allison, Hsun-Lun Aaron Huang, Beate Kiese, Yu-Yun Ho, and Silke Appel-Dingemanse

Pharmacokinetics and Bioavailability of the Novel Rivastigmine Transdermal Patch Versus Rivastigmine Oral Solution in Healthy Elderly Subjects
J Clin Pharmacol 2008 48: 246. [Full Text] [PDF]  

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