90% confidence Intervals for IVRT [Nonparametrics]
Hello all,
I need help regarding In Vitro Release Testing of semisolid dosage forms.
Here is the guidance given by the FDA in page 22 of 40.
In Vitro Release Testing - FDA
My doubt is, How the 90% confidence Intervals are calculated..?
I was tried with "Mann-Whitney Median Confidence Interval with Hodges-Lehmann estimation" using below formula.
90% CI= mn/2 ± Zcrit*(sqrt((mn*(m+n+1))/12)
Lower limits are matching with guidance but not upper limits with only one digit difference. Here is my calculation for 6Runs, 2Runs and 2Runs with one cell missing.
Edit: Tabulators changed to spaces and BBcoded; see also this post #6. URL corrected. Please don’t link to a Google-India search term. [Helmut]
I need help regarding In Vitro Release Testing of semisolid dosage forms.
Here is the guidance given by the FDA in page 22 of 40.
In Vitro Release Testing - FDA
My doubt is, How the 90% confidence Intervals are calculated..?
I was tried with "Mann-Whitney Median Confidence Interval with Hodges-Lehmann estimation" using below formula.
90% CI= mn/2 ± Zcrit*(sqrt((mn*(m+n+1))/12)
Lower limits are matching with guidance but not upper limits with only one digit difference. Here is my calculation for 6Runs, 2Runs and 2Runs with one cell missing.
m 18 6 5
n 18 6 6
mn 324 36 30
mn/2 162 18 15
(mn(m+n+1))/12 999 39 30
sqrt(above) 31.60696126 6.244997998 5.477225575
zcrit 1.645 1.645 1.645
zcrit*sqrt(D14) 51.99345127 10.27302171 9.010036071
L 110 8 6
U 214 28 24
Edit: Tabulators changed to spaces and BBcoded; see also this post #6. URL corrected. Please don’t link to a Google-India search term. [Helmut]
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Best Regards,
GM
Best Regards,
GM
Complete thread:
- 90% confidence Intervals for IVRTGM 2017-10-30 06:22 [Nonparametrics]
- 90% confidence Intervals for IVRT GM 2017-11-01 06:51
- 90% confidence Intervals for IVRT zizou 2017-11-01 19:49
- critical values Helmut 2017-11-01 23:07
- critical values GM 2017-11-02 06:21
- critical values Helmut 2017-11-01 23:07