one study, one method [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2019-03-13 17:23  – Posting: # 20026
Views: 688

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
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,490 posts in 4,135 threads, 1,336 registered users;
online 9 (0 registered, 9 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 13:42 UTC

No rational argument will have a rational effect on a man
who does not want to adopt a rational attitude.    Karl R. Popper

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5