US FDA
ganaish@yahoo.com
             
I keep six honest serving-men;
(They taught me all I knew);
Their names are
What and Why and When
And How and Where and Who

Rudyard Kipling, The Elephant's Child
If you want to get somewhere, you have to know where you want to go and how to get there.
Then
NEVER, NEVER, NEVER GIVE UP."

Norman Vincent Peale
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Guidance Documents - A Preview
Many of us find it difficult to find the appropriate guidance documents of various regulatory agencies. As an initial attempt, I started building this web page in 2004, putting together guidelines for bioavailability and bioequivalence studies under one page.  I hope everyone can easily access the documents without getting lost in the web. I would highly appreciate if you could let me know of any missing documents or any updated guidelines. Please feel
free to email me at
ganaish@yahoo.com or sign in my guest book for your comments.   

Enjoy!. Click on the respective countries to go to their guidelines.
Other Pharmacokinetics resources

PharmPK
An excellent site to learn the basics of pharmacokinetics and pharmacodynamics, maintained by Dr. David Bourne, OHSU.  He also moderates a discussion forum wherein experts from academics and industry  participate to offer their opinions/ideas and solve any queries on issues in pharmacokinetics and pharmacodynamcis.

Basic Pharmacokinetics
Another helpful resource to learn basics of pharmaockinetics by
Dr. Micahel Makoid, Creighton University.

Interactive Clinical Pharmacology

e-pharmacokinetics

Pharmacometrics Resousrces:
Some links to learn anout the basics of pharmacometrics are as follows

Dr. Nick Holford's Web Page

ACCP website

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