PharmPK Discussion - Bioequivalence websites

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On 17 Mar 2000 at 21:48:30, ktisocki (ktisocki.-at-.healthnet.zw) sent the message


Dear All

Can you point me to some fast-loading website containing easy to review
information on bioeqiuvalence studies for regulatory purposes.

Thanks

Klara
______________________________
Dr. Klara Tisocki
Department of Clinical Pharmacology
University of Zimbabwe
Medical School
PO Box A178
Harare,
Zimbabwe

Tel:  263 4 791 631 ext 120
Fax:  263 4 790233

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On 19 Mar 2000 at 20:49:31, "David S. Farrier" (DFarrier.-at-.SummitPK.com) sent the message


Klara,

Of some interest might be the FDA final regulations (1996) on
Bioequivalence which you can download or review at the following web site:

http://www.fda.gov/cvm/fda/infores/guidelines/bioeq96/bioeqapril1996.html

HTH,

David

David S. Farrier, Ph.D.
Summit Research Services
1374 Hillcrest Drive
Ashland, OH 44805 USA
Tel/Fax:  (419)-289-9207
Email:     DFarrier.-a-.SummitPK.com
Web Site: www.SummitPK.com

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On 20 Mar 2000 at 21:07:40, Abdullah_Hassen.-a-.hc-sc.gc.ca sent the message


for Canadian guidelines please see:
http://www.hc-sc.gc.ca/hpb-dgps/therapeut/htmleng/guidmain.html#bioavail

Abdullah M. Hassen, Ph.D.
Bureau of Pharmaceutical Assessment
Health Canada

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On 21 Mar 2000 at 22:44:42, Laszlo Endrenyi (l.endrenyi.aaa.utoronto.ca) sent the message


The FDA guidances for human bioequivalence studies can be found at
www.fda.gov/cder/guidance/index.htm .  Look in the Biopharmaceutics and
Biopharmaceutics(Draft) sections.  The current guidances for orally
administered immmediate- and extended-release dosage forms are Nos. 15 and
12, respectively. Among the drafts, Nos.1 and 2 present the most important,
general regulatory plans.

Laszlo Endrenyi
University of Toronto

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On 23 Mar 2000 at 23:32:38, David_Bourne (david.-a-.boomer.org) sent the message


[Two replies - db]

X-Sender: ornratl.-at-.pha-02-msg
Date: Thu, 16 Mar 2000 16:16:26 +0700
To: PharmPK.aaa.boomer.org
From: ornratl.-a-.nu.ac.th
Subject: Re: PharmPK Bioequivalence websites

Dear Klara

You can find the bioequivalence guideline and the examples at USFDA website
(http://www.fda.gov/cder/guidance).

Ornrat

---

From: "medical" 
To: 
Subject: Re:  PharmPK Bioequivalence websites
Date: Wed, 22 Mar 2000 09:42:05 +0530
X-Priority: 3

nih.gov
Dr .Amit Taneja

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