Volume 91; Issue 3

Clinical Pharmacology & Therapeutics

Volume 91; Issue 3

1

Personalized Medicine: A Personal View

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 320 KB

english, 2012

2

A Randomized, Placebo-Controlled Study of the Effects of Telcagepant on Exercise Time in Patients With Stable Angina

Palcza, J S, Laethem, T, Heirman, I, Panebianco, D L, Kobalava, Z, Martsevich, S Y, Chaitman, B R, Ho, A P, Behm, M O, Rowe, J F

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 215 KB

english, 2012

3

Steady-State Carbamazepine Pharmacokinetics Following Oral and Stable-Labeled Intravenous Administration in Epilepsy Patients: Effects of Race and Sex

Marino, S E, Birnbaum, A K, Leppik, I E, Conway, J M, Musib, L C, Brundage, R C, Ramsay, R E, Pennell, P B, White, J R, Gross, C R, Rarick, J O, Mishra, U, Cloyd, J C

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 209 KB

english, 2012

4

The Role of Physiologically Based Pharmacokinetic Modeling in Regulatory Review

Huang, S-M, Rowland, M

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 343 KB

english, 2012

5

The State of the Art in the Development of Biosimilars

McCamish, Mark, Woollett, Gillian

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 702 KB

english, 2012

6

(Q)SAR Modeling and Safety Assessment in Regulatory Review

Kruhlak, N L, Benz, R D, Zhou, H, Colatsky, T J

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 112 KB

english, 2012

7

Pharmacogenomic Testing: Knowing More, Doing Better

Lunshof, J E, Gurwitz, D

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 323 KB

english, 2012

8

Adoption of Pharmacogenomic Testing by US Physicians: Results of a Nationwide Survey

Stanek, E J, Sanders, C L, Taber, K A Johansen, Khalid, M, Patel, A, Verbrugge, R R, Agatep, B C, Aubert, R E, Epstein, R S, Frueh, F W

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 179 KB

english, 2012

9

The Critical Path Initiative: Leveraging Collaborations to Enhance Regulatory Science

Barratt, R A, Bowens, S L, McCune, S K, Johannessen, J N, Buckman, S Y

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 324 KB

english, 2012

10

The Innovative Medicines Initiative: A European Response to the Innovation Challenge

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 213 KB

english, 2012

11

Detection of Adverse Drug Reaction Signals Using an Electronic Health Records Database: Comparison of the Laboratory Extreme Abnormality Ratio (CLEAR) Algorithm

Yoon, D, Park, M Y, Choi, N K, Park, B J, Kim, J H, Park, R W

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 174 KB

english, 2012

12

Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval

Eichler, H-G, Oye, K, Baird, L G, Abadie, E, Brown, J, L Drum, C, Ferguson, J, Garner, S, Honig, P, Hukkelhoven, M, Lim, J C W, Lim, R, Lumpkin, M M, Neil, G, O'Rourke, B, Pezalla, E, Shoda, D, Seyfer

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 281 KB

english, 2012

13

High-Risk Prescribing and Incidence of Frailty Among Older Community-Dwelling Men

Gnjidic, D, Hilmer, S N, Blyth, F M, Naganathan, V, Cumming, R G, Handelsman, D J, McLachlan, A J, Abernethy, D R, Banks, E, Le Couteur, D G

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 283 KB

english, 2012

14

Evidence vs. Access: Can Twenty-First-Century Drug Regulation Refine the Tradeoffs?

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 116 KB

english, 2012

15

Shift From Surrogate End Point to Outcome Trials: Implications for Cardiovascular Safety Assessment in Development Programs for Antidiabetic Drugs

Marcinak, J F, Viswanathan, P, Arora, V, Roebel, L E, Strack, T R, Leifke, E

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 293 KB

english, 2012

16

The Prevention and Treatment of Missing Data in Clinical Trials: An FDA Perspective on the Importance of Dealing With It

O'Neill, R T, Temple, R

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 133 KB

english, 2012

17

Transforming Regulatory Science 2012: Making a Difference

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 114 KB

english, 2012

18

Regulatory Innovation in Postmarketing Risk Assessment and Management

Staffa, J A, Dal Pan, G J

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 79 KB

english, 2012

19

Heterotropic Effects on Drug-Metabolizing Enzyme Activities: In Vitro Curiosity Emerges as a Clinically Meaningful Phenomenon (Perhaps?)

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 105 KB

english, 2012

20

Is It Possible for FDA Regulatory Scientists and Industry Scientists to Work Together?

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 182 KB

english, 2012

21

Evidence of CYP3A Allosterism In Vivo: Analysis of Interaction Between Fluconazole and Midazolam

Yang, J, Atkins, W M, Isoherranen, N, Paine, M F, Thummel, K E

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 294 KB

english, 2012

22

Effect of the Market Withdrawal of Carisoprodol on Use of Other Prescribed Drugs With Abuse Potential

Bramness, J G, Furu, K, Skurtveit, S, Engeland, A

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 95 KB

english, 2012

23

Impact of Efavirenz on Intestinal Metabolism and Transport: Insights From an Interaction Study With Ezetimibe in Healthy Volunteers

Oswald, S, Meyer zu Schwabedissen, H E, Nassif, A, Modess, C, Desta, Z, Ogburn, E T, Mostertz, J, Keiser, M, Jia, J, Hubeny, A, Ulrich, A, Runge, D, Marinova, M, Lütjohann, D, Kroemer, H K, Siegmund,

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 269 KB

english, 2012

24

FDA Review Divisions: Performance Levels and the Impact on Drug Sponsors

Milne, C-P, Kaitin, K I

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 197 KB

english, 2012

25

Wrong Questions, Wrong Answers? Are We Getting the Drugs We Need?

Lipworth, W L, Kerridge, I H, Day, R O

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 86 KB

english, 2012

26

Regulatory Science and the Role of the Regulator in Biomedical Innovation

Honig, P K, Huang, S-M

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 100 KB

english, 2012

27

In This Issue

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 75 KB

english, 2012

28

Oral Flurbiprofen Metabolic Ratio Assessment Using a Single-Point Dried Blood Spot

Daali, Y, Samer, C, Déglon, J, Thomas, A, Chabert, J, Rebsamen, M, Staub, C, Dayer, P, Desmeules, J

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 249 KB

english, 2012

29

Induction of CYP2C19 and CYP3A Activity Following Repeated Administration of Efavirenz in Healthy Volunteers

Michaud, V, Ogburn, E, Thong, N, Aregbe, A O, Quigg, T C, Flockhart, D A, Desta, Z

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 279 KB

english, 2012

30

The Right Medicines—Just Not Enough of Them

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 186 KB

english, 2012

31

Highlights

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 258 KB

english, 2012

32

Clinical Pharmacology & Therapeutics 2011: Year in Review

Waldman, S A, Terzic, A

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 435 KB

english, 2012

33

Impediments to Clinical Research in the United States

Kramer, J M, Smith, P B, Califf, R M

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 126 KB

english, 2012

34

Current and Future State of FDA-CMS Parallel Reviews

Messner, D A, Tunis, S R

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 93 KB

english, 2012

35

ASCPT News

Journal:

Clinical Pharmacology & Therapeutics

Year:

2012

Language:

english

File:

PDF, 339 KB

english, 2012