Back to the Top
Dear subscriber's
I'm looking for references about guidlines defined from the FDA, FWH
(Japan) and EMEA (europe) about bioequivalence and PK
If somebody have some pointers on this ...
Many Thank in advance.
Nicolas
Nissakid.at.planete.net
Microsoft Certified Product Specialist
(Team Gates Member),(AUI Member)
The above represents my own opinion not my employer's and does not
necessarily constitute the official policy of my employer. Any opinion
developed through this account represent a private conversation.
Back to the Top
http://www.cvm.fda.gov/fda/infores/guides/bioeq96/bioeqapril1996.html
for FDA bioequivalence
Susan
shoaf.at.clinpharm.niaaa.nih.gov | National Institute on Alcohol Abuse and
I don't speak for NIAAA, | Alcoholism
that's for the PR office. |
Back to the Top
Dear Nicolas,
Regarding to FDA's regulations, you may search the home page of FDA on
internet at
http://www.fda.gov/ , or check the guidance for industry from
Center for Drug Evaluation and Research (CDER), FDA at
http://www.fda.gov/cder/dpe1.htm or http://www.fda.gov/cder/supac.htm
The followings are extracted from the table of contents listed there.
TABLE OF CONTENTS
I. PURPOSE OF GUIDANCE
II. DEFINITION OF TERMS
III. COMPONENTS AND COMPOSITION
IV. SITE CHANGES 13
V. CHANGES IN BATCH SIZE (SCALE-UP/SCALE-DOWN)
VI. MANUFACTURING
VII. IN VITRO DISSOLUTION 23 VIII. IN VIVO BIOEQUIVALENCE STUDIES
IX. REFERENCES
APPENDIX A: NARROW THERAPEUTIC RANGE DRUGS
Wish it could help you to find what you want.
Hsiu-ling
_,-*'*-,_,-*'*-,_,-*'*-,_,-*'*-,_,-*'*-,_,-*'*-,_,-*'*-,_,-*'*-,_,-*
M E R R Y C H R I S T M A S & H A P P Y N E W Y E A R
_,-*'*-,_,-*'*-,_,-*'*-,_,-*'*-,_,-*'*-,_,-*'*-,_,-*'*-,_,-*'*-,_,-*
Hsiu-ling Hsiao, Ph.D.
hsiulin.aaa.itsa.ucsf.edu
Postdoctoral scientist, Leslie Z. Benet Lab, UCSF
Back to the Top
> I'm looking for references about guidlines defined from the FDA, FWH
> (Japan) and EMEA (europe) about bioequivalence and PK
Dear Nicolas
here is the EMEA URL:
http://www.eudra.org/emea/
and the FDA URL:
http://www.fda.gov/
here you will find many downloadable guidelines in Adobe Acrobat format.
I don't know the japanese one.
Good search.
Mauro Bertolino
mauber.aaa.to.flashnet.it
Back to the Top
You might also wish to visit Health Canada's Drugs Programme Web Site at
"http://hwcweb.hwc.ca/hpb/drugs/". A number of guidelines and policies are
available there.
Norm Pound>
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)