Bioequivalence and Bioavailability Forum • FDA RSABE is ISC

FDA RSABE is ISC [🇷 for BE/BA]

posted by Helmut – Vienna, Austria, 2020-07-16 13:11 (928 d 20:14 ago) – Posting: # 21709
Views: 14,539

Hi Detlew,

❝ Why not use the ISC estimate of T-R in the ABE decision in case of swR < 0.029356 (CVwR < 30%)?

❝ Politics? Nostalgia (Since years recommended the Proc MIXED code)?

The guidance “Statistical Approaches to Establishing Bioequivalence” of January 2001 (where the same SAS code is given in APPENDIX E) is still in force. Hence, it is only consistent to give it in the progesterone guidance.

❝ I would opt for the full ISC approach because it may be unambiguously implemented in SAS, R, Phoenix and so on for every replicate design, full or partial :cool: .

Cannot agree more. All problems would vanish.

—
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:

Semireplicated + REML in R ElMaestro 2020-07-10 13:19 [🇷 for BE/BA]
- Semireplicated + REML in R Helmut 2020-07-10 19:03
  - Semireplicated + REML in R ElMaestro 2020-07-10 19:24
    - Avoid partial replicate designs, pleeeze! Helmut 2020-07-11 11:57
      - Avoid partial replicate designs, pleeeze! ElMaestro 2020-07-11 14:43
        
        Braveheart! Helmut 2020-07-11 15:38
        
        Who can help? ElMaestro 2020-07-12 12:28
        
        Who can help? ElMaestro 2020-07-12 13:26
        Update II ElMaestro 2020-07-12 21:36
        
        Update III ElMaestro 2020-07-12 21:46
        
        Final update today ElMaestro 2020-07-12 22:27
        
        Medium rare. Helmut 2020-07-13 13:52
        
        took just 52 hrs to do it :-) ElMaestro 2020-07-13 14:18
        
        Will take much more hours still… Helmut 2020-07-13 15:34
        
        Negative determinant ElMaestro 2020-07-14 03:22
        
        Are we loosers? Helmut 2020-07-14 13:58
        
        "we"? Loosers? ElMaestro 2020-07-14 15:07
        
        Misunderstanding? Helmut 2020-07-14 15:32
        
        Braveheart! ElMaestro 2020-07-13 10:13
        
        Braveheart! Helmut 2020-07-13 14:16
        Braveheart! PharmCat 2020-07-15 14:19
        
        Braveheart! ElMaestro 2020-08-02 17:39
- We were all blind (except Detlew) Helmut 2020-07-15 14:27
  - It is the opposite way around for me ElMaestro 2020-07-15 16:25
    - Desultory thoughts Helmut 2020-07-15 17:33
      - FDA RSABE is ISC d_labes 2020-07-15 18:13
        
        FDA RSABE is ISCHelmut 2020-07-16 11:11
      - Desultory thoughts ElMaestro 2020-07-15 23:06
        
        Desultory thoughts Helmut 2020-07-16 10:59
  - Phoenix - which template? mittyri 2020-07-19 00:42
    - FDA RSABE Project template_ v1.4.phxproj Helmut 2020-07-19 01:45
- "By popular demand": likelihood ElMaestro 2020-07-24 10:07
  - And by the way.... ElMaestro 2020-07-24 12:52
    - And by the way.... PharmCat 2020-08-03 14:24
      - Not understood ElMaestro 2020-08-03 22:55
        
        Not understood PharmCat 2020-08-05 01:41
        
        Not understood ElMaestro 2020-08-05 08:13
        
        Not understood PharmCat 2020-08-05 16:37
        
        Open issues ElMaestro 2020-08-06 21:11
        
        Open issues PharmCat 2020-08-07 00:02
        
        Open issues ElMaestro 2020-08-07 07:49
        
        Open issues PharmCat 2020-08-07 11:29
        
        Still can't make it work ElMaestro 2020-08-07 13:08
        
        Still can't make it work PharmCat 2020-08-07 15:42
        
        Still can't make it work ElMaestro 2020-08-07 16:44
        
        Still can't make it work PharmCat 2020-08-07 18:14
        
        Still can't make it work ElMaestro 2020-08-07 18:23
        
        And now it works ElMaestro 2020-08-07 21:31
        Still can't make it work PharmCat 2020-08-08 01:08
        
        Speed improvement ElMaestro 2020-08-08 12:25
        
        Speed improvement PharmCat 2020-08-08 17:27
        Speed improvement ElMaestro 2020-08-08 18:10
        
        Speed improvement PharmCat 2020-08-09 18:22
        Some tests... PharmCat 2020-08-10 11:48