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RegisterHypogonadal males [Regulatives / Guidelines]
Dear Tina,
If the country of submission is US FDA, it is preferable to recruit only Hypogonadal male subjects as per FDA Individual Product BE Recommendation
FDA may not accept other alternative study population.
❝ For endogenous substances like testosterone, why only hypogonadal males are used as sample population? Is there any alternative to hypogonadal males as recruitment will be difficult to identify subjects.
If the country of submission is US FDA, it is preferable to recruit only Hypogonadal male subjects as per FDA Individual Product BE Recommendation
FDA may not accept other alternative study population.
—
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:
- Hypogonadal males Tina 2014-03-25 15:33
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Hypogonadal malesdrgunasakaran1 2014-03-25 17:24
- Hypogonadal males Helmut 2014-03-25 17:32
- Hypogonadal males Dr_Dan 2014-03-26 08:27
- Hypogonadal males Tina 2014-03-26 09:20
- Hypogonadal males nobody 2014-03-26 09:31
- Hypogonadal males Tina 2014-03-26 09:20
Ing. Helmut Schütz