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RegisterPredose Concentrations [Regulatives / Guidelines]
Dear All,
GM- I have a issue in NCE molecule - toxico kinetic study to be submitted as a part of IND filing. In this I observed that there were concentrations in predose samples of about 5-6 subjects.
When a thorough investigation was carried out, it was found that the predose sample collection was done after the drug was dosed in about 5 minutes of time.
So now there are concentrations in the predose sample which are very random & unable to draw any conclusion of it. Though a Protocol deviation shall be filled by the study director, how shall it be justified either stastically in a regulatory compliant manner.
Thanking you all in advance. Solicit all your responses and views on the above quirey.
Cheers,
Srinivasa reddy.K
Mumbai, India.
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Duplicate post deleted. If you want to change the category of your message please edit it rather than re-posting the same message [Ohlbe]
GM- I have a issue in NCE molecule - toxico kinetic study to be submitted as a part of IND filing. In this I observed that there were concentrations in predose samples of about 5-6 subjects.
When a thorough investigation was carried out, it was found that the predose sample collection was done after the drug was dosed in about 5 minutes of time.
So now there are concentrations in the predose sample which are very random & unable to draw any conclusion of it. Though a Protocol deviation shall be filled by the study director, how shall it be justified either stastically in a regulatory compliant manner.
Thanking you all in advance. Solicit all your responses and views on the above quirey.
Cheers,
Srinivasa reddy.K
Mumbai, India.
--
Duplicate post deleted. If you want to change the category of your message please edit it rather than re-posting the same message [Ohlbe]
Complete thread:
- Predose ConcentrationsSrinivasa reddy.K 2009-10-09 08:31
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