Log in
RegisterLevothyroxine BE [Design Issues]
Dear All,
Could someone provide information (articles) about linear pharmacokinetics of strenghts of levothyroxine sodium (25, 50, 75, 88, 100, 112, 125, 137, 150, 200 and 300 ug).
I intend to develop a BE study with the highest strength and ask for biowaiver to the lowest strenghts, because a dose of 600ug (2x 300ug) should be given to detect T4 above baseline levels according FDA Guidance (Levothyroxine Sodium Tablets — In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing - 2000).
Regards,
Daniel Rossi de Campos
Brazil
--
Edit: moved to previous thread. [HS]
Could someone provide information (articles) about linear pharmacokinetics of strenghts of levothyroxine sodium (25, 50, 75, 88, 100, 112, 125, 137, 150, 200 and 300 ug).
I intend to develop a BE study with the highest strength and ask for biowaiver to the lowest strenghts, because a dose of 600ug (2x 300ug) should be given to detect T4 above baseline levels according FDA Guidance (Levothyroxine Sodium Tablets — In Vivo Pharmacokinetic and Bioavailability Studies and In Vitro Dissolution Testing - 2000).
Regards,
Daniel Rossi de Campos
Brazil
--
Edit: moved to previous thread. [HS]
Complete thread:
- Levothyroxine formulations drcampos 2007-04-24 04:46 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Levothyroxine BEdrcampos 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 BEdrcampos 2007-07-19 21:56
Ing. Helmut Schütz