PharmPK Discussion - AAPS-FDA Drug stability recommendations

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On 26 Jul 2007 at 08:15:25, "Nicolas Jean-Marie" (Jean-Marie.Nicolas.at.UCB-Group.com) sent the message


Dear all -
The recommendations of the 3rd AAPS/FDA Bioanalytical Workshop got
recently published in aaps 2007; 9: E30-E42. It is mentioned that
drug stability experiments should be conducted in "unaltered matrix".
Does it imply that frozen plasma cannot be used anymore ? This might
have a considerable impact for those who do not have a local access
to fresh plasma. I guess I am not the only one getting frozen dog and
monkey plasma from commercial sources.
Does anybody have a clear understanding of this new recommendation ?

Jean-Marie NICOLAS
UCB S.A. Pharma

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