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RegisterBlinding in Canadian BE Study [Regulatives / Guidelines]
Dear Mr Pravin,
As per Canadian Guidelines, If possible, the study should be conducted in such a way that the subject is not aware of which product (test or reference) is being administered. Furthermore, the person checking for adverse reactions and the person conducting the analysis of samples should not know which product was administered. Other individuals involved in the administration of the drugs, the surveillance of the patients, or the analysis of plasma data should not know which product was administered.
Reference
As per Canadian Guidelines, If possible, the study should be conducted in such a way that the subject is not aware of which product (test or reference) is being administered. Furthermore, the person checking for adverse reactions and the person conducting the analysis of samples should not know which product was administered. Other individuals involved in the administration of the drugs, the surveillance of the patients, or the analysis of plasma data should not know which product was administered.
Reference
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Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Complete thread:
- Blinding in Canadian BE Study pravin17 2012-05-09 09:07 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Blinding in Canadian BE Studydrgunasakaran1 2012-05-09 11:21
- Blinding in Canadian BE Study akinapally 2012-05-09 12:23
- Blinding in Canadian BE Study jag009 2012-05-10 15:11
- Blinding in Canadian BE Study akinapally 2012-05-11 06:16
Ing. Helmut Schütz