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I would like to answer someone who os more in to the bioequivalence
studies thing than I, if we cas use AUClast instead of AUC inf to
claim bioequivalence for some drug product? And if so, in what
situation?
Thank you?
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The following message was posted to: PharmPK
From the Guidance for the Industry: BA/BE Studies for Orally
Administered Drug Products - General Considerations, 2003
Long Half-Life Drugs
"In a BA or pharmacokinetic study involving an oral product with a long
half-life drug, adequate characterization of the half-life calls for
blood sampling over a long period of time. For a BE determination of an
oral product with a long half-life drug, a nonreplicate, single-dose,
crossover study can be conducted, provided an adequate washout period is
used. If the crossover study is problematic, a BE study with a parallel
design can be used. For either a crossover or parallel study, we
recommend that sample collection time be adequate to ensure completion
of gastrointestinal transit (approximately 2 to 3 days) of the drug
product and absorption of the drug substance. Cmax and a suitably
truncated AUC can be used to characterize peak and total drug exposure,
respectively. For drugs that demonstrate low intrasubject variability in
distribution and clearance, an AUC truncated at 72 hours (AUC0-72 hr)
can be used in place of AUC0-t or AUCinf. For drugs demonstrating high
intrasubject variability in distribution and clearance, AUC truncation
warrants caution. In such cases, we also recommend that sponsors and/or
applicants consult the appropriate review staff."
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The following message was posted to: PharmPK
Dear Bragafarm,
in the EU the primary parameter for extent of BA is AUClast (called
AUCt in the Note for Guidance) providing 80% of AUCinf is covered.
An exception are long half life drugs, where a truncated area
approach (e.g., AUC0-72) may be applied.
Best regards,
Helmut
--
Helmut Schuetz
BEBAC
Consultancy Services for Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna/Austria
tel/fax +43 1 2311746
Web http://BEBAC.at
BE/BA Forum http://forum.bebac.at
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The following message was posted to: PharmPK
Dear Elena,
concerning your reply to Bragafarm's answer on simvastatin.
He was talking about AUClast and AUCinf, not a truncated area
approach: half life of the main active metabolite simvastatin-beta-
hydroxy acid about 2 hours, parent even faster. ;-)
Best regards,
Helmut
--
Helmut Schuetz
BEBAC
Consultancy Services for Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna/Austria
tel/fax +43 1 2311746
Web http://BEBAC.at
BE/BA Forum http://forum.bebac.at
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