PharmPK Discussion - Bioequivalence

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On 30 Sep 2000 at 10:52:39, Young-Joo Lee (leeyj.aaa.plaza.snu.ac.kr) sent the message


Dear All
I'm looking for documents about requisite of facilities conducting
bioequivalence study.
Is there any guidelines about that point in Europe or USA or Japan etc=A1=A6=
?.

Especially, I'm gathering the information about this.
1. Legal qualification of director of study - existence or no existence of
such regulation
2. Requisite of institution - existence or no existence of such regulation

Document or personal comment, anything will be fine.
If somebody have some pointers on this ...Many Thank in advance.

  -------
   Young-Joo Lee, Ph.D.
   E-mail: leeyj.aaa.plaza.snu.ac.kr

  --------

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On 1 Oct 2000 at 22:18:06, ml11439.at.goodnet.com sent the message


Dr.Lee,

     You may or may not already know this, but the FDA website
may be helpful:

The FDA guidances for human bioequivalence studies can be found at
www.fda.gov/cder/guidance/index.htm .

                               Mike Leibold, PharmD, RPh
                               ML11439.at.goodhet.com

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