Bioequivalence and Bioavailability Forum • Levothyroxine Sample size and study design

Levothyroxine Sample size and study design [Power / Sample Size]

posted by lakshmiprasad – India, 2018-04-11 17:09 (2426 d 06:15 ago) – Posting: # 18666
Views: 5,050

Dear All,

I would like to Know that regarding the sample size for levothyroxine sodium, I had gone through the all available literature's for sample size the levothyroxine sodium ISCV was found the below 18%. But the sample size was taken 72 or more than 50. if CV is below the 18% THEN what is the reason behind to considered 70 subjects :confused:

.

Even OGD also It was mentioned as design is fully replicate but all literature's it was mentioned 2 way cross over.

I am thinking due to base line correction, this molecule will show any more variability?

Please guide me levothyroxine is variable drug or not.

if it was not variable in literature why it was mentioned 72 subjects.

thanks & Regards

N. L. D. Prasad

Complete thread:

Levothyroxine Sample size and study designlakshmiprasad 2018-04-11 15:09 [Power / Sample Size]
- Levothyroxine Sample size and study design jag009 2018-04-12 22:47
- Levothyroxine Sample size and study design bebac_fan 2018-04-12 22:49
- Levothyroxine Sample size and study design balakotu 2018-04-13 07:15
  - Levothyroxine Sample size and study design lakshmiprasad 2018-04-14 12:55