planning of bioequivalence sampling [Bioanalytics]

posted by dshah  – India/United Kingdom, 2021-11-01 09:34 (236 d 04:20 ago) – Posting: # 22665
Views: 1,026

(edited by dshah on 2021-11-01 12:29)

Dear Selwa ts!
Generally you can get below conclusion from guidelines...
1. You need to capture absorption phase with on an average 3-4 time points. 1st time point should not be Cmax.
2. Capture the distribution phase by 3-4 time points.
3. Capture the elimination phase by 4-5 time points.

Study duration can be truncated to 72 hrs as per regulatory requirement or else the duration should be sufficient to capture the AUCt/AUC0-inf>0.8.

You can have different time points for fasting and fed study if they are studied separately.
The above requirement is minimum requirement and you can increase the time points if the blood loss is permissible by ethics committee.
You can consider that generally 16-24 time points are there in BE study.
As per FDA-"For most drugs we recommend that 12 to 18 samples, including a pre-dose sample, be collected per subject per dose. This sampling should continue for at least three or more terminal elimination half-lives of the drug to capture 90 percent of the relevant AUC."

Regards,
Dshah

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