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RegisterNumber of tablets - Retention at two different CROs [Regulatives / Guidelines]
Dear Dr. Dan
Thanks for the clarification.
Yes, these studies are to be conducted according to FDA regulations for an ANDA application. Please note that these two studies (fasting and fed) are to be conducted at two different CRO's. The CRO's are not linked to each other. One is located in India and other is located in US. kindly let me know of your expert opinion over this particular scenario for retention of IP's.
Thanks once again.
Regards
Sonu
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
Thanks for the clarification.
Yes, these studies are to be conducted according to FDA regulations for an ANDA application. Please note that these two studies (fasting and fed) are to be conducted at two different CRO's. The CRO's are not linked to each other. One is located in India and other is located in US. kindly let me know of your expert opinion over this particular scenario for retention of IP's.
Thanks once again.
Regards
Sonu
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
Complete thread:
- Number of tablets - Retention at two different CROs scorp2011 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 CROsscorp2011 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 CROsscorp2011 2014-03-19 12:30
- Number of tablets - Retention at two different CROs Dr_Dan 2014-03-18 11:52
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