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I wondered if anyone could refer me to publications (articles or book
chapters) that propose how one might methodically evaluate pharmacokinetic
and pharmacodynamic trials, e.g., study design issues and pitfalls as well
as analysis and interpretation issues.
I would like to use this publication as a teaching tool in a Study Design
Course being given to first year pharmacy students here at UCSF.
Thanks in advance.
Nancy C. Sambol, Pharm.D.
Associate Clinical Professor
Dept. of Biopharmaceutical Sciences
School of Pharmacy
University of California San Francisco
San Francisco CA 94143-0446
ph: 415-476-8884 fax: 415-476-9330
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[Two replies - db]
From: "Ralph Quadflieg"
To:
Subject: Re: PharmPK Evaluating PK and PD Trials
Date: Tue, 13 Oct 1998 17:44:17 +0200
X-Priority: 3
MIME-Version: 1.0
Dear Mrs. Sambol,
Try to contact Adam Cohen at the Centre for Human Drug Research (CHDR) in
Leiden, The Netherlands.(Zernikedreef 10,2333 CL Leiden, The Netherlands,
Fax.: +31 71 246499) He published a book about three years ago, which deals
with conducting studies, data safety, data analysis etc.
As far as I know he is Professor for Klincal Pharmacology of the University
of Leiden.
Ralph Quadflieg
Dept.Pharm.Techn.Biopharm.
University of Bonn
An der Immenburg 4
D-53121 Bonn
Germany
quadflieg.at.uni-bonn
http://www.pharma.uni-bonn.de/pharmtech/
Tel.: ++49 228 218997
Fax.:++49 228 735268
---
X-Sender: vlewis.-a-.mail.db.uth.tmc.edu
Date: Tue, 13 Oct 1998 15:46:33 -0500
To: PharmPK.-at-.pharm.cpb.uokhsc.edu
From: "Vahn Lewis"
Subject: Re: PharmPK Evaluating PK and PD Trials
Mime-Version: 1.0
Dr. Peter Welling has published a new edition of his book Pharmacokinetics:
Processes, Mathematics and Applications 2nd ed. , published by the American
Chemical Society in 1997. He spent the last three chapters discussing the
use of pharmacokinetics in drug discovery and drug trials. You should
probably look this book over to see if it would be useful to you.
This is a nice little book (400 pages) written at the practical level (I
think it is intended for use in the drug industry) full of good
information. In addition, he includes problems for students to work on and
even better, has the answers for them in the back of the book! I feel that
it would be perfect for students in a pharmacokintics course : Except for
the price, $105. Dr. Welling and the ACS would possibly make a lot more
money on the book if they would price it a level that pharmacy and other
heath professional students could afford. If it were in the under $50
range I think it would probably become the standard. It does basic
pharmacokinetics really well.
He even discusses physiological based pharmacokinetic models (PBPK). I
which he would have included Ball and Schwartz's CMATRIX approach, Comp.
Biol.Med #4 269-276, 1994 and perhaps a bit more on computer modeling but
still its a great beginning book.
I don't know if you are aware of it but you might have your class check out
the CDER website. http://www.fda.gov/cder/ It includes information about
what the FDA wants from drug developers.
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