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)


Edit: Category changed; see also this post #1. Please follow the Forum’s Policy[Helmut]
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
★★★
avatar
Homepage
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
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Activity
 Admin contact
21,214 posts in 4,427 threads, 1,481 registered users;
online 12 (0 registered, 12 guests [including 8 identified bots]).
Forum time: Friday 20:23 UTC (Europe/Vienna)

Biostatistician. One who has neither the intellect for mathematics
nor the commitment for medicine but likes to dabble in both.    Stephen Senn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5