Bioequivalence and Bioavailability Forum

Karmegams ☆ India, 2011-06-16 06:53 (5482 d 05:51 ago) Posting: # 7132 Views: 6,325	CV from pilot study or reported literature [Power / Sample Size] Post reply
	Dear Sir, The intra-subject CV from pilot study or reported literature is used in sample size calculation for bioequivalence study. The intra-subject CV is due to drug and formulation. So, is it appropriate to use CV-intra from literature of other’s product (others’ formulation) for sample size calculation? Regards Skar

Helmut
★★★

Vienna, Austria,
2011-06-16 15:12
(5481 d 21:32 ago)

@ Karmegams
Posting: # 7139
Views: 5,283

Credibility of data

Post reply

Dear Skar!

❝ Dear Sir,

▲ Not interested in ladies’ opinions‽

❝ The intra-subject CV is due to drug and formulation.

Not quite. You should also consider

design issues (number and location of sampling time points, single dose vs. steady state),
clinical setting (food, posture, physical activity), and
analytical variability (mainly stability and to a lesser degree the method itself).

❝ So, is it appropriate to use CV-intra from literature of other’s product (others’ formulation) for sample size calculation?

Yes, but try to judge the credibility of the study. Add a safety margin. Using the plain number ‘as is’ I would consider careless.

Don’t forget your previous thread and today’s quote:

Statistics are no substitute for judgment. Henry Clay

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Karmegams
☆

India,
2011-06-17 13:57
(5480 d 22:47 ago)

@ Helmut
Posting: # 7148
Views: 5,225

Credibility of data

Post reply

Dear HS,

Thank you very much for your explaination.

❝ ❝ The intra-subject CV is due to drug and formulation.

❝ Not quite. You should also consider

design issues (number and location of sampling time points, single dose vs. steady state),
clinical setting (food, posture, physical activity), and
analytical variability (mainly stability and to a lesser degree the method itself).

If the study is well designed and conducted in standardised and controlled manner, i believe that the variability due to design issues, clinical setting and analytical method is very less or negligible.

Regards,
Skar

GSTATS
☆

India,
2011-06-16 22:02
(5481 d 14:42 ago)

@ Karmegams
Posting: # 7142
Views: 5,273

CV from pilot study or reported literature

Post reply

Dear Skar,

❝ The intra-subject CV from pilot study or reported literature is used in sample size calculation for bioequivalence study.

I would suggest to go with CV from pilot study, done in-house, if it is there. So that one could have a variability from population in which pivotal study is planned. If not, then no other option but to search literature for CV.

Regards,
GSTATS

—
Let Noble Thoughts come from Every Side: RIG VEDA

rajneesh singh ☆ 2011-06-17 12:14 (5481 d 00:30 ago) @ GSTATS Posting: # 7147 Views: 5,278	CV from pilot study or reported literature Post reply
	Dear Skar, Justification for sample size should be appropriate regrading Design & Formulation. we can use suitable literature otherwise it is not available then we go for pilot study. Regards, RS Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]

CV from pilot study or reported literature [Power / Sample Size]

Credibility of data

Credibility of data

CV from pilot study or reported literature

CV from pilot study or reported literature