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RegisterRetention quantity for Europe Submission study [Regulatives / Guidelines]
Dear
How much units of Investigational Product need to be kept as retention for pharmacodynamic study conducted for Europe submission?
Is there any relation between number of units used for the study and number of units retained as retention sample?
Please give your view and if possible, give reference of relevant guideline / Directive.
Thanks
Pradeep Labana
How much units of Investigational Product need to be kept as retention for pharmacodynamic study conducted for Europe submission?
Is there any relation between number of units used for the study and number of units retained as retention sample?
Please give your view and if possible, give reference of relevant guideline / Directive.
Thanks
Pradeep Labana
Complete thread:
- Retention quantity for Europe Submission studyachintparikh 2012-11-03 12:44
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- Retention quantity for Europe Submission study drgunasakaran1 2012-11-03 13:02
- Retention quantity for Europe Submission study achintparikh 2012-11-07 06:01
- Retention quantity for Europe Submission study drgunasakaran1 2012-11-03 13:02
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