Critical Path Initiative
TABLE OF CONTENTS
Volume 81, Issue 2 (February 2007)
Editorial |
News and Views |
Perspectives |
State of the Art |
Research |
Discovery & Development |
Regulation & Use
Contents
Contents
In this issue
Clin Pharmacol Ther 81: 139; doi:10.1038/sj.clpt.6100093
See also: Commentary by JonesSee also: Commentary by BenetSee also: Commentary by BreckenridgeSee also: Editorial by Buckman et al. See also: Discovery by Shi et al. See also: Translational Medicine by Chinn & KroetzSee also: Practice by Bradley & ShenEditorial
Editorial
Medical Product Development and Regulatory Science for the 21st Century: The Critical Path Vision and Its Impact on Health Care
S Buckman, S-M Huang and S Murphy
Clin Pharmacol Ther 81: 141-144; doi:10.1038/sj.clpt.6100085
News and Views
Highlights
Highlights
Clin Pharmacol Ther 81: 146-147; doi:10.1038/sj.clpt.6100076
ASCPT News
2007 Scientific awardees
Clin Pharmacol Ther 81: 148-149; doi:10.1038/sj.clpt.6100077
Books
Herbal Supplements–Drug Interactions: Scientific and Regulatory Perspectives
C A Haller
Clin Pharmacol Ther 81: 150-151; doi:10.1038/sj.clpt.6100041
Macroscopy
Biomarker Development, Commercialization, and Regulation: Individualization of Medicine Lost in Translation
C Wilson, S Schulz and S A Waldman
Clin Pharmacol Ther 81: 153-155; doi:10.1038/sj.clpt.6100088
Perspectives
Commentaries
The Institute of Medicine's Report on Drug Safety: Constructive and Ambitious, But Does It Go Far Enough?
J K Jones
Clin Pharmacol Ther 81: 156-158; doi:10.1038/sj.clpt.6100086
Review and Critique of the Institute of Medicine Report "The Future of Drug Safety"
L Z Benet
Clin Pharmacol Ther 81: 158-161; doi:10.1038/sj.clpt.6100083
The Future of Drug Safety
A Breckenridge
Clin Pharmacol Ther 81: 161-163; doi:10.1038/sj.clpt.6100079
State of the Art
State of the Art
The Prospects for "Personalized Medicine" in Drug Development and Drug Therapy
J Woodcock
Clin Pharmacol Ther 81: 164-169; doi:10.1038/sj.clpt.6100063
Paving the Critical Path: How can Clinical Pharmacology Help Achieve the Vision?
L J Lesko
Clin Pharmacol Ther 81: 170-177; doi:10.1038/sj.clpt.6100045
Research
Articles
Clinical Pharmacology of 1,4-Butanediol and Gamma-hydroxybutyrate After Oral 1,4-Butanediol Administration to Healthy Volunteers
D Thai, J E Dyer, P Jacob and C A Haller
Clin Pharmacol Ther 81: 178-184; advance online publication, December 27, 2006; doi:10.1038/sj.clpt.6100037
VKORC1 and CYP2C9 Genotypes and Phenprocoumon Anticoagulation Status: Interaction Between both Genotypes Affects Dose Requirement
T Schalekamp, B P Brassé, J F M Roijers, E van Meegen, F J M van der Meer, E M van Wijk, A C G Egberts and A de Boer
Clin Pharmacol Ther 81: 185-193; advance online publication, December 27, 2006; doi:10.1038/sj.clpt.6100036
Effect of OATP1B Transporter Inhibition on the Pharmacokinetics of Atorvastatin in Healthy Volunteers
Y Y Lau, Y Huang, L Frassetto and L Z Benet
Clin Pharmacol Ther 81: 194-204; advance online publication, December 27, 2006; doi:10.1038/sj.clpt.6100038
Effect of Pioglitazone on the Metabolic and Hormonal Response to a Mixed Meal in Type II Diabetes
A Gastaldelli, A Casolaro, M Pettiti, M Nannipieri, D Ciociaro, S Frascerra, E Buzzigoli, S Baldi, A Mari and E Ferrannini
Clin Pharmacol Ther 81: 205-212; doi:10.1038/sj.clpt.6100034
Impact of Pharmacometric Reviews on New Drug Approval and Labeling Decisions—a Survey of 31 New Drug Applications Submitted Between 2005 and 2006
V A Bhattaram, C Bonapace, D M Chilukuri, J Z Duan, C Garnett, J V S Gobburu, S H Jang, L Kenna, L J Lesko, R Madabushi, Y Men, J R Powell, W Qiu, R P Ramchandani, C W Tornoe, Y Wang and J J Zheng
Clin Pharmacol Ther 81: 213-221; doi:10.1038/sj.clpt.6100051
Depo-medroxyprogesterone in Women on Antiretroviral Therapy: Effective Contraception and Lack of Clinically Significant Interactions
S E Cohn, J-G Park, D H Watts, A Stek, J Hitti, P A Clax, S Yu and J J L Lertora for the ACTG A5093 Protocol Team
Clin Pharmacol Ther 81: 222-227; advance online publication, December 27, 2006; doi:10.1038/sj.clpt.6100040
CYP3A5 Genotype Markedly Influences the Pharmacokinetics of Tacrolimus and Sirolimus in Kidney Transplant Recipients
L Renders, M Frisman, M Ufer, I Mosyagin, S Haenisch, U Ott, A Caliebe, M Dechant, F Braun, U Kunzendorf and I Cascorbi
Clin Pharmacol Ther 81: 228-234; advance online publication, December 27, 2006; doi:10.1038/sj.clpt.6100039
Anticholinergic Drugs and Physical Function Among Frail Elderly Population
F Landi, A Russo, R Liperoti, M Cesari, C Barillaro, M Pahor, R Bernabei and G Onder
Clin Pharmacol Ther 81: 235-241; advance online publication, December 27, 2006; doi:10.1038/sj.clpt.6100035
Cytochrome P4502D6 (CYP2D6) Gene Locus Heterogeneity: Characterization of Gene Duplication Events
A Gaedigk, L Ndjountché, K Divakaran, L DiAnne Bradford, I Zineh, T F Oberlander, D C Brousseau, D G McCarver, J A Johnson, S W Alander, K Wayne Riggs and J Steven Leeder
Clin Pharmacol Ther 81: 242-251; doi:10.1038/sj.clpt.6100033
Modeling of Brain D2 Receptor Occupancy-Plasma Concentration Relationships with a Novel Antipsychotic, YKP1358, Using Serial PET Scans in Healthy Volunteers
K S Lim, J S Kwon, I-J Jang, J M Jeong, J S Lee, H W Kim, W J Kang, J-R Kim, J-Y Cho, E Kim, S Y Yoo, S-G Shin and K-S Yu
Clin Pharmacol Ther 81: 252-258; doi:10.1038/sj.clpt.6100049
Discovery & Development
Discovery
GARDASIL®: Prophylactic Human Papillomavirus Vaccine Development – From Bench Top to Bed-side
L Shi, H L Sings, J T Bryan, B Wang, Y Wang, H Mach, M Kosinski, M W Washabaugh, R Sitrin and E Barr
Clin Pharmacol Ther 81: 259-264; doi:10.1038/sj.clpt.6100055
Translational Medicine
ABCB1 Pharmacogenetics: Progress, Pitfalls, and Promise
L W Chinn and D L Kroetz
Clin Pharmacol Ther 81: 265-269; doi:10.1038/sj.clpt.6100052
Development
Appropriate Phenotyping Procedures for Drug Metabolizing Enzymes and Transporters in Humans and Their Simultaneous Use in the "Cocktail" Approach
U Fuhr, A Jetter and J Kirchheiner
Clin Pharmacol Ther 81: 270-283; doi:10.1038/sj.clpt.6100050
Regulation & Use
Practice
Overview of Management of Atrial Fibrillation in Symptomatic Elderly Patients: Pharmacologic Therapy Versus AV Node Ablation
D J Bradley and W-K Shen
Clin Pharmacol Ther 81: 284-287; doi:10.1038/sj.clpt.6100062
Public Policy
Distinguishing Product and Practice Regulation in Personalized Medicine
B J Evans
Clin Pharmacol Ther 81: 288-293; doi:10.1038/sj.clpt.6100042
The Experience with Voluntary Genomic Data Submissions at the FDA and a Vision for the Future of the Voluntary Data Submission Program
M S Orr, F Goodsaid, S Amur, A Rudman and F W Frueh
Clin Pharmacol Ther 81: 294-297; doi:10.1038/sj.clpt.6100053
Drug Interaction Studies: Study Design, Data Analysis, and Implications for Dosing and Labeling
S-M Huang, R Temple, D C Throckmorton and L J Lesko
Clin Pharmacol Ther 81: 298-304; doi:10.1038/sj.clpt.6100054
