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RegisterLevothyroxine formulations [Design Issues]
Dear All,
I would like to evaluate the disposition of lower dosages of levothyroxine formulations, i.e 12,5 mg and 37.5 mg (new formulations). Considering the FDA Guidance it is necessary a dose of 600 mcg for avoinding baseline effect. So, the problem is the dose (48 tablets x 12.5 mcg = 600 mcg). Does someone have experience with these studies?
Regards,
Daniel
I would like to evaluate the disposition of lower dosages of levothyroxine formulations, i.e 12,5 mg and 37.5 mg (new formulations). Considering the FDA Guidance it is necessary a dose of 600 mcg for avoinding baseline effect. So, the problem is the dose (48 tablets x 12.5 mcg = 600 mcg). Does someone have experience with these studies?
Regards,
Daniel
Complete thread:
- Levothyroxine formulationsdrcampos 2007-04-24 04:46
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Levothyroxine BE drcampos 2007-07-19 21:56
- Levothyroxine BE pjs 2015-07-29 11:32
- BE of a solution, NTID or not… Helmut 2015-07-29 12:43
- BE of a solution, NTID or not… pjs 2015-07-29 13:05
- BE of a solution, NTID or not… Helmut 2015-07-29 12:43
- Levothyroxine BE pjs 2015-07-29 11:32
- Levothyroxine BE drcampos 2007-07-19 21:56
Ing. Helmut Schütz