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

posted by JP2030 – Saudi Arabia, 2023-10-18 07:58 (551 d 06:19 ago) – Posting: # 23763
Views: 3,149

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

Complete thread:

Delayed Release Formulation -AUC truncated at 72 h (AUC(0-72h))JP2030 2023-10-18 05:58 [Regulatives / Guidelines]
- EMA: No AUC(0-72h) for all MR products Helmut 2023-10-18 07:09

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

Complete thread:

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