Bioequivalence and Bioavailability Forum

logistical limitations = opportunities? [General Statistics]

posted by Dr_Dan – Germany, 2010-03-12 10:04 (5940 d 15:23 ago) – Posting: # 4901
Views: 6,608

Dear all
Advantage of interim stats: with some luck you'd even need to include fewer subjects than first feared.
Disadvantage: with some bad luck you'd even need include more than first feared due to analyses conducted at adjusted significance levels. Furthermore an interim analysis takes time (you have to perform the bioanalysis of the PK samples before starting the second group). For a generic company this is a strong argument.
If you follow Helmut's suggestion ensure that bioanalysis will not start before the subjects of the second group are enrolled.
Kind regards
Dan

—
Kind regards and have a nice day
Dr_Dan

Complete thread:

large sample size boonchai_l 2010-03-11 08:04
- two groups (logistics) Helmut 2010-03-11 12:36
  - logistical limitations = opportunities? ElMaestro 2010-03-11 21:09
    - logistical limitations = opportunities?Dr_Dan 2010-03-12 09:04
      - Sequential design = opportunity (IMHO) Helmut 2010-03-12 12:21
        
        Sequential design = opportunity (IMHO) Dr_Dan 2010-03-12 13:04
        
        Tasseography Helmut 2010-03-12 15:01
        
        sequential replicate design Dr_Dan 2010-03-15 11:21
        
        sequential replicate design (reference?) Helmut 2010-03-15 15:37
  - two groups (logistics) boonchai_l 2010-03-16 12:25
    - two groups (logistics) ElMaestro 2010-03-18 18:21

logistical limitations = opportunities? [General Sta­tis­tics]

Complete thread:

logistical limitations = opportunities? [General Statistics]