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