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rana ☆ India, 2012-09-14 13:32 (5037 d 00:45 ago) Posting: # 9217 Views: 3,118 |
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Dear Helmut, For Europe submission our fasting and fed studies for X molecule 90% CI of AUC is falling in between 90.00% to 111.00%. In this case steady state study can be waived for Europe submission? Regards, Rana. |
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drgunasakaran1 ★★  2012-09-14 15:09 (5036 d 23:07 ago) @ rana Posting: # 9218 Views: 2,634 |
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Dear Mr Rana, If your X molecule is a Prolonged Release Formulation meant for EMA submission, then you need to conduct Steady State Study also. You cannot waive the Steady state study based on Fasting and Fed studies results in case of Prolonged Release formulation. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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Helmut ★★★   Vienna, Austria, 2012-09-14 16:05 (5036 d 22:12 ago) @ rana Posting: # 9221 Views: 2,582 |
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Dear Rana! ❝ For Europe submission our fasting and fed studies for X molecule 90% CI of AUC is falling in between 90.00% to 111.00%. In this case steady state study can be waived for Europe submission? Agree with Dr. Gunasakaran; waiving MD studies under this conditions was only considered by the PK-group in the early phase of developing the new MR GL – but AFAIK is “off the table” for a good while. Let’s wait for the draft (which should be ready by the end of this month). — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz