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Back to the forum  2018-06-20 07:17 CEST (UTC+2h)

long half life drug bioequivalence study design [Design Issues]

posted by ssussu - China, 2017-08-16 11:45  - Posting: # 17690
Views: 2,857

Dear all,
I have questions on the BE study design of long half life drug, please kindly give me some advice. According to FDA GL:
You can use Cmax and a suitably truncated AUC to characterize peak and total drug exposure, respectively. For drugs that demonstrate low intrasubject variability in distribution and clearance, you can use an AUC truncated at 72 hours (AUC0-72 hr) in place of AUC0–t or AUC0–inf.
The question is
Should I just need to design the sampling time to 72hr or need to longer than 72hr?
If I just sampling for 72hr, how can I prove the drug is a long half life drug?

Best regards!

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