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Ramesh Ramalingam
Junior

India,
2018-06-18 08:00

Posting: # 18913
Views: 884
 

 > 5% of Cmax for endogenous molecule? [Regulatives / Guidelines]

Dear All,

As per guidelines, Subjects with non-zero baseline concentrations > 5% of Cmax. Such data should be excluded from bioequivalence calculation.

Is it applicable for endogenous molecule? could you please suggest anyone..



Regards,
Ramesh. R
Helmut
Hero
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Homepage
Vienna, Austria,
2018-06-18 10:59

@ Ramesh Ramalingam
Posting: # 18914
Views: 742
 

 Any own thoughts?

Hi Ramesh,

» As per guidelines, Subjects with non-zero baseline concentrations > 5% of Cmax. Such data should be excluded from bioequivalence calculation.
» Is it applicable for endogenous molecule?

All your posts are in the category Regulatives / Guidelines.
Remember that our job is not exegesis but science. Hence, what do you think?

Cheers,
Helmut Schütz
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Ramesh Ramalingam
Junior

India,
2018-08-08 07:29

@ Helmut
Posting: # 19159
Views: 443
 

 carryover effect in endogenous substances

Dear Helmut,

As per previous discussion. We con't directly assess the carry-over effect for endogenous substances. As per USFDA regulatory requirement we have to approach the concept of 5% cmax for endogenous substances also https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM234960.pdf. but they are not clearly telling about how to approach these concept for endogenous substances.

Kindly share your suggestions about to below statements.
When dealing with endogenous substances, the presence of carry-over effects is very difficult to quantify. Therefore to find a proof of absence or presence of carryover effect in endogenous substances, the pre-dose (baseline) drug concentrations for Period 1 should compared to the pre-dose concentrations for Period 2. Thus, previous period average pre-dose concentration should be subtracted with subsequent period average pre-dose concentration after that the resulted values should compare with 5% of cmax. Based on this we can ensure the carry over effect occurred or not in period 1 or in subsequent period.


Regards,
Ramesh.R
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