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Registerbioequivalence study design of vaginal ring [Design Issues]
Hi ElMaestro,
That’s nice, actually I work on Ethinyl Estradiol; Etonogestrel (0.015 mg/24 hr; 0.12 mg/24 hr) for US submission.
Dose: single ring for 21 days (Per day ring release 0.015 mg EE and 0.12 mg Etonogestrel) “that mean is like a multiple dose study“ ?
Draft guidance mentioned:
Two way cross over
Bioequivalence based on (90% CI): Ethinyl estradiol and etonogestrel
What is the primary PK parameters ? is it Cmax, AUC0-t and AUC0-∞ or Css (Steady state parameters ) ?
What’s the sampling schedule for this study ?
Regards
Mahesh
That’s nice, actually I work on Ethinyl Estradiol; Etonogestrel (0.015 mg/24 hr; 0.12 mg/24 hr) for US submission.
Dose: single ring for 21 days (Per day ring release 0.015 mg EE and 0.12 mg Etonogestrel) “that mean is like a multiple dose study“ ?
Draft guidance mentioned:
Two way cross over
Bioequivalence based on (90% CI): Ethinyl estradiol and etonogestrel
What is the primary PK parameters ? is it Cmax, AUC0-t and AUC0-∞ or Css (Steady state parameters ) ?
What’s the sampling schedule for this study ?
Regards
Mahesh
Complete thread:
- bioequivalence study design of vaginal ring Mahesh M 2014-07-15 12:59
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- bioequivalence study design of vaginal ring ElMaestro 2014-07-15 13:44
- bioequivalence study design of vaginal ringMahesh M 2014-07-16 07:06
- bioequivalence study design of vaginal ring luvblooms 2014-07-16 08:12
- bioequivalence study design of vaginal ring Mahesh M 2014-07-16 08:52
- bioequivalence study design of vaginal ring luvblooms 2014-07-16 08:12
- bioequivalence study design of vaginal ringMahesh M 2014-07-16 07:06
- bioequivalence study design of vaginal ring ElMaestro 2014-07-15 13:44
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