Bioequivalence and Bioavailability Forum

No problem with same strength but different doses [General Sta­tis­tics]

posted by Helmut  – Vienna, Austria, 2013-07-18 01:17 (4314 d 18:13 ago) – Posting: # 11011
Views: 9,397

Hi Vasily!

❝ We said that it is not ethical since some subjects will get more drug than needed (risk of AEs), some subjects will get less drug (risk of tumor resistance).

Exactly. What else?

❝ We also provided a link to the FDA capecitabine GL.

Nice.

❝ Experts said that ok, the design is now acceptable and commented that we have to analyze the subset of the sample with the similar amount of drug taken.

Shit.

❝ I understand that this expert's position does not have strong scientific background, however obviously I cannot tell it to the expert.

You have to say it in a polite way. The expert should not loose his/her face. Ask ElMaestro (our expert for clever wordings) for help. Since you used only one strength I don’t see a problem. The capecitabine guidance is a nice reference.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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

Complete thread:

• Dose based on m² VK 2013-07-17 10:35 [General Sta­tis­tics] 
  • Dose based on m² Dr_Dan 2013-07-17 11:09
    • Dose based on m² VK 2013-07-17 16:17
  • Different doses or strenghts? Helmut 2013-07-17 12:18
    • Different doses or strenghts? VK 2013-07-17 16:31
      • No problem with same strength but different dosesHelmut 2013-07-17 23:17
      • Different doses or strenghts? luvblooms 2013-07-18 06:42
        • Different doses or strenghts? VK 2013-07-18 15:28
          • Different doses or strenghts? kumarnaidu 2013-11-21 14:00
            • Different doses or strenghts? Dr_Dan 2013-11-21 15:23
              • Different doses or strenghts? kumarnaidu 2013-11-22 05:34