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Tina ★ India, 2014-03-25 16:33 (4476 d 23:00 ago) Posting: # 12708 Views: 4,089 |
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Dear forum members, 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. For steroids, we use normal volunteers instead of adrenal deficient patients? So why only for testosterone the difference? Kind regards, Tina |
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drgunasakaran1 ★★  2014-03-25 18:24 (4476 d 21:10 ago) @ Tina Posting: # 12709 Views: 3,496 |
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Dear Tina, ❝ 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 |
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Helmut ★★★   Vienna, Austria, 2014-03-25 18:32 (4476 d 21:02 ago) @ Tina Posting: # 12710 Views: 3,520 |
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Hi Tina, ❝ Is there any alternative to hypogonadal males as recruitment will be difficult to identify subjects. Castrati? Eunuchs? With the descent of the Baroque Opera and Harems apparently being less popular nowadays, they are a rare breed. Don’t think about recruiting normal males. A kick in the balls is painful enough but a shot of testosterone is not what most guys desire (body-builders excluded). — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Dr_Dan ★★ Germany, 2014-03-26 09:27 (4476 d 06:06 ago) @ Tina Posting: # 12712 Views: 3,408 |
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Dear Tina If you want to perform a study with hypogonadal males you should go to a country with a centralized health system. This helps in order to recruit this special study population. I once performed such a BE study in Turkey. I hope this helps. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
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Tina ★ India, 2014-03-26 10:20 (4476 d 05:14 ago) @ Dr_Dan Posting: # 12714 Views: 3,423 |
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Dear all, Thank you for the advice. Kind regards, Tina |
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nobody nothing 2014-03-26 10:31 (4476 d 05:02 ago) @ Tina Posting: # 12715 Views: 3,433 |
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From the FDA Guidance "...any subject with pre-dose concentration more than 5% of their Cmax should be excluded from BE statistical analysis" Good reason, huh?  — Kindest regards, nobody |
Ing. Helmut Schütz