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RegisterNumber of tablets - Retention at two different CROs [Regulatives / Guidelines]
Dear Team,
Please guide me:
Study 1 of XYZ product conducted at CRO 1. Now we are planning to conduct Study 2 of same XYZ product at a different CRO 2. Please suggest the requirement for retention of investigational products to be retained. Do we need to retain samples required for 5-times release test at each CRO (say for example 300 samples at CRO 1 and 300 samples at CRO 2) or else will a total of 300 samples combined at both the CRO's will suffice (say for example 200 at CRO 1 and 100 at CRO 2).
Regards
Sonu
Please guide me:
Study 1 of XYZ product conducted at CRO 1. Now we are planning to conduct Study 2 of same XYZ product at a different CRO 2. Please suggest the requirement for retention of investigational products to be retained. Do we need to retain samples required for 5-times release test at each CRO (say for example 300 samples at CRO 1 and 300 samples at CRO 2) or else will a total of 300 samples combined at both the CRO's will suffice (say for example 200 at CRO 1 and 100 at CRO 2).
Regards
Sonu
Complete thread:
- Number of tablets - Retention at two different CROsscorp2011 2014-03-18 07:35
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Number of tablets - Retention at two different CROs Dr_Dan 2014-03-18 11:52
- Number of tablets - Retention at two different CROs scorp2011 2014-03-19 12:30
- Number of tablets - Retention at two different CROs Ohlbe 2014-03-19 14:12
- Number of tablets - Retention at two different CROs scorp2011 2014-03-19 12:30
- Number of tablets - Retention at two different CROs Dr_Dan 2014-03-18 11:52
Ing. Helmut Schütz