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Is it necessary for preclinical ADME studies (other than
toxicokinetics) to be GLP?
Are there guidances defining this more clearly or is it an indirect
interpretation of what is said and not said in the various guidances?
I would appreciate any insight. Thanks much!
*****
Peter Underwood, Pharm.D.
Clinical Pharmacist
Jarosz Regulatory Services, Inc.
1634 W. Wildwood Rd.
Whitewater, WI 53190 USA
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The following message was posted to: PharmPK
Dear Peter,
I hope you find this helpful - we certainly did!
GLP practices are clearly laid out by the FDA and other government
groups in the USA. Some web sites of interest should include the
following and by searching for "GLP" to begin with will be a big help.
http://www.fda.gov/cder/guidance/index.htm
http://www.fda.gov/ora/compliance_ref/bimo/glp/default.htm
Also know the differences between GMPs and GLPs and address those issues
prior to clinical trials requests. Google GMP and GLP will give a lot
of information.
Cheers!
Russell
Russell Higbee, MS, PhD, DVM
Senior Scientist
VaxDesign Corporation
2721 Discovery Dr.
Suite 400
Orlando, FL 32826 USA
www.vaxdesign.com
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