EMA: No AUC(0-72h) for all MR products [Regulatives / Guidelines]
❝ 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.
A truncated AUC(0-72h) is not acceptable for MR products.On page 26:
Single dose: AUC(0-t), AUC(0-∞), CmaxScientifically this does not make sense for DR products…
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- 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 productsHelmut 2023-10-18 07:09