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The following message was posted to: PharmPK
I have a question about how one should handle the smaples collected
for PK/PD when a clinical study ends prematurely (due to non-response
determined duing interim analysis). The samples have been collected
for many of the patients but is there a regulatory obligation to
conduct the bioanalysis and PK/PD analysis or can we amend the
protocol and discard the samples (to save cost and time)?
Thanks in advance,
Vernon
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The following message was posted to: PharmPK
Vernon-
I am familiar with similar cases in which the clinical protocol was
amended to say that analyses will not be performed.
Thomas L. Tarnowski, Ph. D.
Dept. Head (Dep), Drug Metabolism and Pharmacokinetics
Roche Palo Alto
3431 Hillview Avenue, Palo Alto, CA 94304
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