Bioequivalence and Bioavailability Forum • When is a BE study futile?

When is a BE study futile? [Power / Sample Size]

posted by Helmut – Vienna, Austria, 2011-10-31 15:41 (5350 d 06:04 ago) – Posting: # 7566
Views: 9,572

Dear ElMaestro!

I would also go with 80%. If you want to get some hints from various re(li)gions:

US-FDA: ≥80%
Canada-HPFB/TGD: ≥80%
Generally ICH E9 Section 3.5 is applicable:
‘The number of subjects in a clinical trial should always be large enough to provide a reliable answer to the questions addressed.’
Only New Zealand’s Medsafe suggests to accept lower power in certain cases:
‘If the calculated number of subjects appears to be higher than is ethically justifiable, it may be necessary to accept a statistical power which is less than desirable. Normally it is not practical to use more than about 40 subjects in a bioavailability study.’
Note that n=40 translates into 80% power, T/R 0.95, CV 30% in a 2×2 cross-over.

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

[image]

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

Complete thread:

When is a BE study futile? ElMaestro 2011-10-31 09:17
- When is a BE study futile? Dr_Dan 2011-10-31 09:46
  - When is a BE study futile? ElMaestro 2011-11-01 09:59
    - Power in the 2-stage design d_labes 2011-11-01 10:28
- When is a BE study futile? Dr_Dan 2011-10-31 12:55
- When is a BE study futile?Helmut 2011-10-31 14:41
  - When is a BE study futile? vinayshed 2011-11-01 05:59
- Minimum target power? d_labes 2011-11-01 10:04
  - ethics and power ElMaestro 2011-11-01 10:46
    - ethics and power d_labes 2011-11-01 11:28
      - ethics and power Ohlbe 2011-11-01 22:57
        
        ethics and power ElMaestro 2011-11-02 09:27
        
        ethics and power Ohlbe 2011-11-02 11:00
    - ethics and power Dr_Dan 2011-11-01 13:10
      - ethics and power ElMaestro 2011-11-01 13:53
        
        When does power become unethical? Dr_Dan 2011-11-02 10:55
        
        When does power become unethical? ElMaestro 2011-11-02 12:01

Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
133 visitors (0 registered, 133 guests [including 30 identified bots]).
Forum time: 22:46 CEST (Europe/Vienna)

Scientists often have a naïve faith that
if only they could discover enough facts about a problem,
these facts would somehow arrange themselves
in a compelling and true solution. Theodosius Dobzhansky

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC

Ing. Helmut Schütz