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RegisterSubject population to be enrolled [Regulatives / Guidelines]
Dear all
I need clarity regarding the subject population to be enrolled for the USFDA study for Drospirenone;Ethinyl Estradiol tablets Oral contraceptive.
As per the OGD guidance
1) Drospirenone;Ethinyl Estradiol 3 mg/0.02 mg tablets
Subjects:Healthy nonpregnant females, general population
2) Drospirenone;Ethinyl Estradiol 3 mg/0.03 mg tablets
Subjects: Healthy males and nonpregnant females, general population
Since Drospirenone;Ethinyl Estradiol is indicated in female subjects, whether we can conduct study on both male and female subjects ?.
Also what is mean by word "general population" Is it for both male and female subjects?
I need clarity regarding the subject population to be enrolled for the USFDA study for Drospirenone;Ethinyl Estradiol tablets Oral contraceptive.
As per the OGD guidance
1) Drospirenone;Ethinyl Estradiol 3 mg/0.02 mg tablets
Subjects:Healthy nonpregnant females, general population
2) Drospirenone;Ethinyl Estradiol 3 mg/0.03 mg tablets
Subjects: Healthy males and nonpregnant females, general population
Since Drospirenone;Ethinyl Estradiol is indicated in female subjects, whether we can conduct study on both male and female subjects ?.
Also what is mean by word "general population" Is it for both male and female subjects?
Complete thread:
- Subject population to be enrolledpash413 2014-11-10 11:23 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Subject population to be enrolled Dr_Dan 2014-11-10 14:52
- Subject population to be enrolled drgunasakaran1 2014-11-10 18:42
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