JP2030
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Saudi Arabia,
2023-10-18 07:58
(50 d 00:24 ago)

Posting: # 23763
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 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
Helmut
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Vienna, Austria,
2023-10-18 09:09
(49 d 23:13 ago)

@ JP2030
Posting: # 23764
Views: 727
 

 EMA: No AUC(0-72h) for all MR products

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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