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The following message was posted to: PharmPK
Dear All
Does any body know any guidlines indicating the conditions and
acceptance criteria for repeating the analysis of the plasma samples in the
bioequivalence study ?
What is the acceptable difference between the old and new results and
what
are the conditions where the repitition is allowed
Thanks
Sami
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The following message was posted to: PharmPK
Dear Sami,
Please see page 18 of the guideline below (Topic: Repeat Analysis)
The FDA guidelines on Bioanalytical Methods
(http://www.fda.gov/cder/guidance/4252fnl.htm)
Regards,
Charina
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