Delayed Release For­mu­la­tion -AUC trun­cated at 72 h (AUC(0-72h)) [Regulatives / Guidelines]

posted by JP2030 – Saudi Arabia, 2023-10-18 07:58 (277 d 05:18 ago) – Posting: # 23763
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Dear All,

Please share your opinion on Delayed-Release Tablets can we use study design AUC truncated at 72 h (AUC(0-72h)) for EU Submission? It's acceptable.

Terminal Elimination Half-Life (T1/2el) of the drug is 67 hrs.

Thanks in advance for your response.

Regards,
JP2030

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