EMA: No AUC(0-72h) for all MR products [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2023-10-18 09:09 (54 d 01:45 ago) – Posting: # 23764
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Hi JP2030,

❝ 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.

See the applicable guideline page 25:

A truncated AUC(0-72h) is not acceptable for MR products.

On page 26:

Single dose: AUC(0-t), AUC(0-∞), Cmax

Scientifically this does not make sense for DR products…

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