Delayed Release Formulation -AUC truncated at 72 h (AUC(0-72h)) [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.
Thanks in advance for your response.