Phenotyping [Design Issues]

posted by Essar – 2006-03-01 09:24 (7070 d 09:33 ago) – Posting: # 79
Views: 11,300

❝ If you plan a cross-over multiple dose study for such a drug, you may consider phenotyping in screening for safety reasons (i.e., include only FMs; otherwise you will end up in toxic range for the PMs). Example: paroxetine.


Dear Helmut,
Thanks for the clarification. Would need one more clarification:

Do we need to carry out Phenotyping for the single-dose, cross-over study also. We are planning to do the single-dose, cross-over BE study for Risperidone Tablets, and we have included phenotyping in this study. The justification provided by the concerned people is "to cancel out the inter-subject variability". But my question is that do we really require phenotyping in this study. Also, if inter-subject variability is a question, it will be taken care of by ANOVA. What do you suggest? Please enlighten.

Regards,
Essar

Complete thread:

UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,689 registered users;
58 visitors (0 registered, 58 guests [including 6 identified bots]).
Forum time: 19:57 CEST (Europe/Vienna)

If I’d observed all the rules,
I’d never have got anywhere.    Marilyn Monroe

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