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Dear All,
Do you know what are the regulatory requirements for an extended
release formulation of a previously approved immediate-release drug?
Is there a need to have bioequivalence for both Cmax and AUC?
Thanks in advance for your help
Nathalie Toublanc
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The following message was posted to: PharmPK
Dear Nathalie,
you cannot describe or anticipate a strict bioequivalence between an
ER (Extended Release and an IR (Immediate Release) formulation.
The PK profile of an ER formulation should exhibit differences as
compared to the PK profile of an IR formulation : a delayed Tmax, a
lower Cmax and a steady-state which ensures the presence of the drug
with an efficient concentration in the plasma for a relative long
time, and an AUC which should probably be higher.
Coming back to your question I would suggest that you show a relevant
PK profile of the ER vs the IR commercial dosage form to satisfy
regulatory issues.
Your ER formulation will be relevant if the PK profile is relevant as
compared to the IR form PK profile.
Best regards,
Frederic Doc
ACRITER - Drug discovery consulting
www.acriter-consulting.com
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