Back to the Top
The following message was posted to: PharmPK
Does anyone know of a guidance that specifies a retention period
specifically for pharmacokinetic samples (i.e. serial aliquots of plasma
and or blood) specific to drug registration applications?
If not, then what is normally acceptable practice? Surely any retention
period would have to be validated to ensure that specimens are stable?
Thanks very much.
Regards,
Jennifer Norman
Quality Assurance
Division of Pharmacology
University of Cape Town
Tel. +27 (0)21 406 6498
Fax. +27 (0)21 448 1989
Back to the Top
The following message was posted to: PharmPK
Jennifer Norman
Please refer http://www.fda.gov/cder/guidance/4843dft.pdf
Handling and Retention of BA and BE Testing Samples
With regards
Prashant
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)