Zobrazeno 1 - 10
of 122
pro vyhledávání: '"Wayne A. Colburn"'
Autor:
Karin A. Kook, Markian S. Jaworsky, Steve K. Teo, William Tracewell, Michael A. Scheffler, David I. Stirling, Wayne A. Colburn, Steve D. Thomas, Oscar L. Laskin
Publikováno v:
Clinical Pharmacokinetics. 43:311-327
Thalidomide is a racemic glutamic acid derivative approved in the US for erythema nodosum leprosum, a complication of leprosy. In addition, its use in various inflammatory and oncologic conditions is being investigated. Thalidomide interconverts betw
Autor:
Jean W. Lee, Wayne A. Colburn
Publikováno v:
Clinical Pharmacokinetics. 42:997-1022
Four elements are crucial to successful pharmacokinetic-pharmacodynamic (PK/PD) modelling and simulation for efficient and effective rational drug development: (i) mechanism-based biomarker selection and correlation to clinical endpoints; (ii) quanti
Autor:
Wayne A. Colburn, Karin A. Kook, Steve K. Teo, Steve D. Thomas, David I. Stirling, Michael R. Scheffler, William Tracewell
Publikováno v:
The Journal of Clinical Pharmacology. 41:662-667
Thalidomide is approved in the United States for treating erythema nodosum leprosum, a complication of leprosy. The present study determined the single-dose oral pharmacokinetics and dose proportionality from 50 to 400 mg of Celgene's commercial Thal
Autor:
Gregory J. Downing, Carl C. Peck, Arthur J. Atkinson, Robert T. Schooley, Daniel F. Hoth, Victor G. DeGruttola, John A. Oates, Janet Woodcock, Wayne A. Colburn, Scott L. Zeger, David L. DeMets, Bert A. Spilker
Publikováno v:
Clinical Pharmacology & Therapeutics. 69:89-95
Autor:
Wayne A. Colburn
Publikováno v:
The Journal of Clinical Pharmacology. 40:1419-1427
Biomarkers and surrogate endpoints are critical to the future of efficient drug development. Definitions, a conceptual model, and a conceptual framework for validating and bridging biomarkers to clinical endpoints are provided in this presentation. I
Autor:
Donald R. Stanski, Wayne A. Colburn, Philip Chaikin, Hartmut Derendorf, Raymond Miller, Gerald R. Rhodes, Jürgen Venitz, Robert L. Powell, Lawrence J. Lesko, Peter Lee
Publikováno v:
The Journal of Clinical Pharmacology. 40:1399-1418
The two domains in clinical pharmacology dealing with optimizing dosing recommendations are pharmacokinetics and pharmacodynamics. However, the usefulness of these disciplines is limited if viewed in isolation. Pharmacokinetic/pharmacodynamic (PK/PD)
Autor:
Karin A. Kook, William G. Tracewell, David I. Stirling, Steve D. Thomas, Steve K. Teo, Michael R. Scheffler, Wayne A. Colburn
Publikováno v:
Biopharmaceutics & Drug Disposition. 21:33-40
The effect of food on the oral pharmacokinetics of thalidomide and the relative bioavailability of two oral thalidomide formulations were determined in an open label, single dose, randomized, three-way crossover study. Five male and eight female heal
Publikováno v:
The Journal of Clinical Pharmacology. 39:1162-1168
Thalidomide was recently approved in the United States for the treatment of erythema nodosum leprosum, a complication of leprosy. The present study determined the bioequivalence and pharmacokinetics of Celgene's commercial and clinical trial thalidom
Publikováno v:
The Journal of Clinical Pharmacology. 39:1032-1037
Tacrolimus (FK506, Prograf) is marketed for the prophylaxis of organ rejection following allogenic liver or kidney transplantation. A previously conducted, randomized, 24-subject, crossover bioavailability study of 1 and 5 mg capsules (one period eac
Publikováno v:
The Journal of Clinical Pharmacology. 38:1021-1024
This study was designed to determine the steady-state relative bioavailability of ganciclovir after three dosage regimens designed to deliver 6,000 mg/day. The study design was an open-label, randomized, three-treatment crossover design in which 22 h