Bioequivalence and Bioavailability Forum

❝ seems that you have a high budget. That’s nice and decrease your changes of failure (producer’s risk β = 1 – power).

- Than twice the cost of failure to invest in one successfully doing is considered a profit.

❝ But: Most guidelines suggest a power of 80–90%; you may run into problems with the Ethics Committee. It’s the job of the EC to judge the risk of subjects (drug effects, common risks due to repetitive venipuncture, AEs, etc.) and the advantage for the health system (cheaper drugs). It’s not the job of the EC to decrease the risk of failure of a pharmaceutical company, which is commonly 10–20%. You can give it a try with 95% power (if you expect a high drop-out rate), but I don’t think that any EC will accept 99% power (more than doubling the sample size from 80% power; example below for T/R 0.95):

❝             CV%

❝ power│ 15  20  25  30

❝ ─────┼───────────────

❝  80  │ 12  20  28  40

❝  90  │ 16  26  38  52

❝  95  │ 18  32  46  66

❝  99  │ 26  44  68  94

❝

❝ There’s another pitfall. Did you ever come across the term ‘forced bioequivalence’? The sponsor suspects that the test will deviate a lot from the reference but will not present a sample size estimation based on that. Instead a sample size estimation with high power for a better (though not realistic) value is presented. Example:

❝ ∆ 11% (T/R 89%), n=44, 79.9% power (realistic; not presented)

❝ ∆  5% (T/R 95%), n=44, 99.1% power (presented)

• All of the comments I receive a case of empathy.
  
• But one kind of different opinions, some more than 80% or 90% of the test to make sure once you reach a positive result as doing the rights of the subjects that can guarantee the Doors
  
• In South Korea did not bring positive results if the re-test.
  So far no clear rules for re-test has not been established.
  Do you know of other countries to review the re-test regulations?

❝ Regulators might not like that. Quote: We are interested in public health – not in the profit of the pharmaceutical industry.

The public health is my first priority will be to work

Thank you for giving me feedback

BJ