80% confidence ? [Power / Sample Size]
Dear Helmut!
.
In Patterson, Jones "BIOEQUIVALENCE and STATISTICS in CLINICAL PHARMACOLOGY", Chapter 5.7, page 164 (of my copy) in the text it is mentioned "... with an upper 50% confidence bound ..." which is clearly a typo.
If I try to verify their example (Table 5.6) I get the upper confidence bound mentioned only if I use alpha=5%.
BTW: I nevertheless are the opinion that a 95% CI is too stringent.
But have no reference for it. Patterson and Jones cite Gould in this context.
Gould, A.L. (1995) Group sequential extensions of a standard
bioequivalence testing procedure.
J. Pharmacokinetics and Biopharmaceutics, 23, 57–86.
Since I don't have this on file yet, I can't verify if this is also only a typo?
❝ In the thread mentioned above I used a 95% CI, which is quite over-weary… Patterson & Jones (2006) recommend an 80% one-sided-interval (or the common producer's risk of 20%).

In Patterson, Jones "BIOEQUIVALENCE and STATISTICS in CLINICAL PHARMACOLOGY", Chapter 5.7, page 164 (of my copy) in the text it is mentioned "... with an upper 50% confidence bound ..." which is clearly a typo.
If I try to verify their example (Table 5.6) I get the upper confidence bound mentioned only if I use alpha=5%.
BTW: I nevertheless are the opinion that a 95% CI is too stringent.
But have no reference for it. Patterson and Jones cite Gould in this context.
Gould, A.L. (1995) Group sequential extensions of a standard
bioequivalence testing procedure.
J. Pharmacokinetics and Biopharmaceutics, 23, 57–86.
Since I don't have this on file yet, I can't verify if this is also only a typo?
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- Sample Size BA/BE Sriraj 2010-02-26 14:32 [Power / Sample Size]
- Sample Size BA/BE Helmut 2010-03-01 14:00
- Sample size for a pilot study to estimate the CVintra yjlee168 2010-03-01 19:25
- Sample size for a pilot study to estimate the CVintra Helmut 2010-03-01 21:01
- Sample size for a pilot study to estimate the CVintra yjlee168 2010-03-01 23:47
- Sample size for a pilot study to estimate the CVintra Helmut 2010-03-03 19:04
- Sample size for a pilot study to estimate the CVintra yjlee168 2010-03-04 22:35
- Sample size for a pilot study to estimate the CVintra Helmut 2010-03-03 19:04
- 80% confidence ?d_labes 2010-03-19 13:02
- 75% confidence... Helmut 2010-03-19 14:12
- Sample size for a pilot study to estimate the CVintra yjlee168 2010-03-01 23:47
- Sample size for a pilot study to estimate the CVintra ElMaestro 2010-03-01 22:23
- Sample size for a pilot study to estimate the CVintra yjlee168 2010-03-02 00:02
- Sample size for a pilot study to estimate the CVintra Helmut 2010-03-02 02:19
- Sample size for a pilot study to estimate the CVintra yjlee168 2010-03-29 13:27
- Sample size for a pilot study to estimate the CVintra ElMaestro 2010-03-29 13:39
- Sample size for a pilot study to estimate the CVintra yjlee168 2010-03-29 13:47
- Sequential designs (history and future) Helmut 2010-03-29 14:19
- Sequential designs (history and future) yjlee168 2010-03-29 19:19
- Sequential designs (history and future) Helmut 2010-03-29 20:43
- Sequential designs (history and future) yjlee168 2010-04-01 18:58
- Sequential designs (WinNonlin vs. bear) Helmut 2010-04-02 21:00
- Sequential designs (history and future) yjlee168 2010-04-01 18:58
- Sequential designs (history and future) Helmut 2010-03-29 20:43
- Sequential designs (history and future) yjlee168 2010-03-29 19:19
- Sample size for a pilot study to estimate the CVintra ElMaestro 2010-03-29 13:39
- Sample size for a pilot study to estimate the CVintra yjlee168 2010-03-29 13:27
- Sample size for a pilot study to estimate the CVintra Helmut 2010-03-01 21:01
- Sample size for a pilot study to estimate the CVintra yjlee168 2010-03-01 19:25
- Sample Size BA/BE Helmut 2010-03-01 14:00