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Multiple dose studies waived based on single dose studies [Regulatives / Guidelines]

posted by rana – India, 2012-09-14 13:32 (5036 d 10:29 ago) – Posting: # 9217
Views: 3,112

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.

Complete thread:

Multiple dose studies waived based on single dose studiesrana 2012-09-14 11:32
- Multiple dose studies waived based on single dose studies drgunasakaran1 2012-09-14 13:09
- MD waiving based on SD 90–111% CI unlikely Helmut 2012-09-14 14:05

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