Bioequivalence and Bioavailability Forum • Switching

Switching - null sWR [RSABE / ABEL]

posted by d_labes – Berlin, Germany, 2010-05-04 16:04 (5524 d 16:32 ago) – Posting: # 5284
Views: 36,545

Dear Dave, dear All,

❝ One thing I was happy about with the FDA progesterone recommendations was that the FDA specified 0.294 for sig_wr, because a few of their previous publications recommended using 0.25, which didn't map close to the 30% intraCV cutoff.

Please note sigma_S=0.294 is only the switching variability i.e. from which on the scaled ABE criterion is allowed if s_WR>sigma_S. In their SAS code the regulatory constant s₀ is still 0.25.
See f.i. on page 6 and 8 of the progesterone draft guidance:
theta=((log(1.25)/0.25)**2
(=0.8925742²)

This leads to the discontinuity at CV=30% and the inflation of the consumer's risk around CV=30% as described by:
L. Endrenyi and L. Tothfalusi
"Regulatory Conditions for the Determination of Bioequivalence of Highly Variable Drugs"
J. Pharm. Pharmaceut. Sci. (www.cspsCanada.org) 12 (1): 138 - 149, 2009

Edit: online resource added. [Helmut]

—
Regards,

Detlew

Complete thread:

Reference scaled BE - FDA (and FARTSSIE update) ddubins 2010-04-26 20:28 [RSABE / ABEL]
- Reference scaled ABE - FDA d_labes 2010-04-27 08:58
  - Reference scaled ABE - FDA ElMaestro 2010-04-27 13:39
    - Factor 2 is unbiased d_labes 2010-04-27 14:30
    - Biased bonus from MoM d_labes 2010-05-04 12:10
      - Biased bonus from MoM ElMaestro 2010-05-04 12:54
        
        Mixed MoM d_labes 2010-05-04 14:40
        
        Mixed MoM ElMaestro 2010-05-04 15:08
        
        R and G, CSH and UN d_labes 2010-05-05 10:42
        
        A sailor gets confused ElMaestro 2010-05-05 11:49
        
        Confused V/Z matratzen and tips d_labes 2010-05-05 14:49
        
        superb post! ElMaestro 2010-05-05 21:32
        
        Gambling with UN d_labes 2010-05-06 11:00
        
        Mixed MoM yjlee168 2010-05-05 09:12
- Reference scaled BE - FDA (and FARTSSIE update) KR 2010-04-27 13:14
- Reference scaled BE - EMA Helmut 2010-04-27 14:58
  - Reference scaled BE - EMA ddubins 2010-04-27 17:52
    - Partial replicate design and FDA ABE code d_labes 2010-04-28 09:47
    - Reference scaled BE - EMA Helmut 2010-04-28 14:46
    - Switching - null sWRd_labes 2010-05-04 14:04
- The unknown x d_labes 2010-05-06 13:26
  - The unknown x jdetlor 2010-09-28 17:22
    - Unknown x corrected? d_labes 2010-10-01 12:14
      - Unknown x corrected? Qilex 2016-09-21 12:25
        
        Official unknown x d_labes 2016-09-21 13:22