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The following message was posted to: PharmPK
Hello all,
Does anyone have some good references on clinical trial simulation? I
would greatly appreciate any that you have.
Matt
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[A few replies - db]
From: Paolo Vicini
Date: Fri, 07 Dec 2001 09:30:20 -0800
To: david.aaa.boomer.org
Subject: Re: PharmPK References on Clinical Trial Simulation
The following message was posted to: PharmPK
Dear Matt,
I would recommend the following references:
Bonate PL. Clinical trial simulation in drug development. Pharm Res.
2000 Mar;17(3):252-6. Review.
Holford NH, Kimko HC, Monteleone JP, Peck CC. Simulation of clinical
trials. Annu Rev Pharmacol Toxicol. 2000;40:209-34. Review.
Nestorov I, Graham G, Duffull S, Aarons L, Fuseau E, Coates P. Modeling
and stimulation for clinical trial design involving a categorical
response: a phase II case study with naratriptan. Pharm Res. 2001
Aug;18(8):1210-9.
Best wishes,
Paolo
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From: "Alan Ma"
Date: Fri, 07 Dec 2001 18:35:42 +0000
To: david.aaa.boomer.org
Subject: Re: PharmPK References on Clinical Trial Simulation
The following message was posted to: PharmPK
Enclosed pls find a good review for the clinical simulation.
Holford NH. Kimko HC. Monteleone JP. Peck CC. Simulation of clinical
trials. [Review] Annual Review of Pharmacology & Toxicology.
40:209-34, 2000.
For the basic concepts of clinical simulation and modeling, pls try
Mathematical modeling of pharmacokinetic data. Bourne DWA.
Hopefully, they are helpful.
Q. Alan Ma
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From: "Ou, Ying"
Date: Fri, 7 Dec 2001 13:55:01 -0500
To: david.aaa.boomer.org
Subject: RE: PharmPK References on Clinical Trial Simulation
The following message was posted to: PharmPK
Hi,
A good place to start is a review paper by Holford N. H. G. et al, Annu.
Rev. Pharmacol. Toxicol. 2000. 40: 209-34, which may be obtained directly
from the Journal web site.
Hope that helps.
Ying Ou, Ph.D.
Non-Clinical Drug Safety Evaluation
Otsuka Maryland Research Institute
9900 Medical Center Drive
Rockville, MD 20850
T 240. 683.3378
F 301. 721.7378
e-mail: yingo.-a-.otsuka.com
---
From: Serge Guzy
Date: Fri, 7 Dec 2001 11:07:35 -0800
To: david.-at-.boomer.org
Subject: RE: PharmPK References on Clinical Trial Simulation
The following message was posted to: PharmPK
I suggest to look at the following link
http://cdds.georgetown.edu/research/sddgp723.html
Serge Guzy
Head of Pharmacometrics
Xoma
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