one study, one method [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-03-13 17:23  – Posting: # 20026
Views: 2,100

Salam Osama,

» […] The use of two methods or technologies within a
» comparative BA/BE study is strongly discouraged:. ( i.e not applicable at all also with cross-validation).:confused::confused:
» Why ??

Honestly, I would not feel comfortable with such an approach as well. Even if two methods are fully validated and cross-validated against each other. Though, at least in a crossover it should be OK.
I faced very few examples that a validated method (you know, only spiked samples…) turned out to perform “not so good” on real samples. In these cases we developed another method and re-analysed all samples with the new method. I cannot imagine a situation when someone would change a suitable method within a study just for fun.

Cheers,
Helmut Schütz
[image]

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

Complete thread:

Activity
 Admin contact
20,255 posts in 4,263 threads, 1,398 registered users;
online 9 (0 registered, 9 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 08:29 UTC

You should treat as many patients as possible with the new drugs
while they still have the power to heal.    Armand Trousseau

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