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I would like to evaluate a modified release formulation (MR) of a
drug that is authorised as an immediate release (IR) formulation.
The EMEA guidance (CPMP/EWP/280/96) says that the MR formulation may
reach a similar total exposure (AUC) to drug as for the IR. So, I
would like to design a single dose study (fasting and fed). The study
would be 2x2 and the MR formulation would be administered as a single
dose versus a IR formulation administered according to the
conventional dosing regimen: MR (1 dose) versus IR (2 doses -
12/12h). I would be evaluated AUC (C.I 90%) within 0.8-1.25 and
CmaxMR/CmaxIR less than 125%. Is it design corrected, considering no
accumulation of the drug (AUCdose interval/AUClast higher than 0.8)?
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