PKS
☆

India,
2019-04-05 06:45
(602 d 13:37 ago)

Posting: # 20125
Views: 2,474

## Clinical end point acceptance limit [Study As­sess­ment]

Should I conclude bio-equivalence with the values of [-0.2025, 0.076] in clinical end point study. Can I assume it as within the interval of (-0.20, 0.20)

ElMaestro
★★★

Belgium?,
2019-04-05 06:51
(602 d 13:31 ago)

@ PKS
Posting: # 20126
Views: 2,138

## Clinical end point acceptance limit

Hello to you too, PKS,

» Should I conclude bio-equivalence with the values of [-0.2025, 0.076] in clinical end point study. Can I assume it as within the interval of (-0.20, 0.20)

What does your protocol say on exactly that matter?

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.
nobody
nothing

2019-04-05 07:04
(602 d 13:19 ago)

@ ElMaestro
Posting: # 20127
Views: 2,136

## Clinical end point acceptance limit

» What does your protocol say on exactly that matter?

Educated guess: nuffin....

Kindest regards, nobody
PKS
☆

India,
2019-04-05 07:17
(602 d 13:05 ago)

@ ElMaestro
Posting: # 20128
Views: 2,122

## Clinical end point acceptance limit

» » Should I conclude bio-equivalence with the values of [-0.2025, 0.076] in clinical end point study. Can I assume it as within the interval of (-0.20, 0.20)
»
» What does your protocol say on exactly that matter?

My protocol says within (-0.20 and 0.20)
Helmut
★★★

Vienna, Austria,
2019-04-05 08:53
(602 d 11:29 ago)

@ PKS
Posting: # 20129
Views: 2,088

## –0.2025 < –0.2, right?

Hi PKS,

I reordered your quotes for clarity.

» My protocol says within (-0.20 and 0.20)
» » » Should I conclude bio-equivalence with the values of [-0.2025, 0.076] in clinical end point study.

No!
{–0.2025, +0.076} {–0.20, +0.20} ∎

Furthermore, ±0.20 of what? Since you are working with untransformed data, possibly  = ±20% of the arithmetic mean of the reference. This was used in the dark ages of BE as well. Hence, the limits were {1 – , 1 + } or {0.8000, 1.2000}. Do you think that {0.7975, 1.0760} would pass?
Or do you want to want to deal directly with (as your protocol suggests) and round the CI to only 2–3* digits in order to pass the limits stated in your own protocol?

» Can I assume it as within the interval of (-0.20, 0.20)

You can assume whatever you like. If you give us the design, sizes (per sequence in a crossover, of groups in a parallel), and the CV we can calculate the α (probability of type I error, aka patient’s risk). However, α will be >0.05 and hence, the chances that authorities will accept the study as proof of equivalence are extremely low.

• IEEE 754  : round(–0.2025, 2) = –0.2 (unbiased from zero)
commercial: round(–0.2025, 3) = –0.2 (biased from zero)

Dif-tor heh smusma 🖖
Helmut Schütz

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