## Variance 'Extraction' [General Statistics]

Dear HS,

This is a pilot three squence, three period crossover study.

1. Ratio for T2/R is around 98.63% and for T1/R is around 50.00%. I guess Variance is too high Which has affected 90% CI for T2/R to go out of Bioequivalence limit.

2. Calculated sample size for ratio T2/R and Using common variance is too high (more than 100).

3. When I did the analysis by blocking T1 from pharmacokinetic output of WinNonlin ratio of T2/R is around 105.00% and CI fall within bioequivalence limit and intraCV is around 27.99% (calculated from variance).

4. Calculated sample size for ratio T2/R and Using variance (intra CV of 27.99%) is around 33.

5. By blocking T1, ANOVA table shows two degree of freedom for Sequence and Period, since there are 3 Sequence and 3 Period.

6. Is my analysis by blocking T1 is correct?

7. Can I use sample size of 36 if a pivotal study is planned for T2 and R?

Regards,

Atish

This is a pilot three squence, three period crossover study.

1. Ratio for T2/R is around 98.63% and for T1/R is around 50.00%. I guess Variance is too high Which has affected 90% CI for T2/R to go out of Bioequivalence limit.

2. Calculated sample size for ratio T2/R and Using common variance is too high (more than 100).

3. When I did the analysis by blocking T1 from pharmacokinetic output of WinNonlin ratio of T2/R is around 105.00% and CI fall within bioequivalence limit and intraCV is around 27.99% (calculated from variance).

4. Calculated sample size for ratio T2/R and Using variance (intra CV of 27.99%) is around 33.

5. By blocking T1, ANOVA table shows two degree of freedom for Sequence and Period, since there are 3 Sequence and 3 Period.

6. Is my analysis by blocking T1 is correct?

7. Can I use sample size of 36 if a pivotal study is planned for T2 and R?

Regards,

Atish

### Complete thread:

- Three way crossover study comparing two T with one R atish_azad 2008-06-27 13:24
- Variance 'Extraction' Helmut 2008-06-27 18:56
- Variance 'Extraction'atish_azad 2008-06-28 07:01
- Variance 'Extraction' Ohlbe 2008-06-28 14:32
- Variance 'Extraction' atish_azad 2008-06-29 10:01
- Variance 'Extraction' Jaime_R 2008-07-11 21:41
- Variance 'Extraction' atish_azad 2008-07-12 18:37
- Variance 'Extraction' Jaime_R 2008-07-14 16:05

- Variance 'Extraction' atish_azad 2008-07-12 18:37

- Variance 'Extraction' Jaime_R 2008-07-11 21:41

- Variance 'Extraction' atish_azad 2008-06-29 10:01

- Variance 'Extraction' Ohlbe 2008-06-28 14:32

- Variance 'Extraction'atish_azad 2008-06-28 07:01

- Variance 'Extraction' Helmut 2008-06-27 18:56