Bioequivalence and Bioavailability Forum • TRT|RTR rulez? References

TRT|RTR rulez? References [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2013-08-14 15:44 (4292 d 10:52 ago) – Posting: # 11285
Views: 10,240

Dear Detlew!

❝ Rulez? Really?

❝ Read chapter 9.3 of Chow and Liu, especially 9.3.4 "Assessment of Intra-Subject Variabilities". And if you have, read it again.

Ok, promised.

❝ ❝ BTW, if you like a reference that’s a design the two Lászlós used in some of their papers / simulations.

❝

❝ Which one do you mean?

Likely all of them. I guess they started with simulations in 2001^1,2 (only 2- and 4-period studies) and referred back to these papers in all followings. In 2007³ László Tóthfalusi recommended TRTR|RTRT and TRT|RTR. Interesting enough no details were given until 2009⁴:

“The power curves were obtained by simulating 10 000 three-period bioequivalence trials with a design of TRT/RTR and 36 subjects.”

Tóthfalusi L, Endrényi L, Midha KK, Rawson MJ, Hubbard JW. Evaluation of the Bioequivalence of Highly-Variable Drugs and Drug Products. Pharm Res. 2001;18(6):728–33.
Tóthfalusi L, Endrényi L. Limits for the Scaled Average Bioequivalence of Highly Variable Drugs and Drug Products. Pharm Res. 2003;20(3):382–9.
L Tóthfalusi L. Scaled Average Bioequivalence to Evaluate Bioequivalence of Highly Variable Drugs. Presentation at the informa conference “Dissolution Testing, Bioavailability & Bioequivalance”, 24 May 2007, Budapest, Hungary
Tóthfalusi L, Endrényi L, García-Arieta A. Evaluation of Bioequivalence for Highly Variable Drugs with Scaled Average Bioequivalence. Clin Pharmacokinet. 2009;48(11):725–43. doi 10.2165/11318040-000000000-00000

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Helmut Schütz

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Complete thread:

3-per, 2-trt designs and estimation of intra-subj. variance ElMaestro 2013-08-12 19:54 [RSABE / ABEL]
- 3-per, 2-trt designs and estimation of intra-subj. variance Dr_Dan 2013-08-13 10:11
  - 3-per, 2-trt designs and estimation of intra-subj. variance ElMaestro 2013-08-13 15:00
    - TRT|RTR rulez! Helmut 2013-08-13 18:23
      - TRT|RTR rulez? Really? d_labes 2013-08-14 08:16
        
        TRT|RTR rulez? Really? Yes. ElMaestro 2013-08-14 11:29
        
        TRT|RTR rulez? Really? No. d_labes 2013-08-14 13:34
        
        TRT|RTR rulez? Really? No. ElMaestro 2013-08-14 14:25
        
        TRT|RTR Lost in formulas. d_labes 2013-08-14 16:35
        
        TRT|RTR rulez? ReferencesHelmut 2013-08-14 13:44
        
        References László & László d_labes 2013-08-14 19:12
        
        Heteroscedasticity Helmut 2013-08-17 17:33
        
        Heteroscedasticity: TRT|RTR rulez! d_labes 2013-08-29 16:45
        
        Heteroscedasticity: TRT|RTR rulez! ElMaestro 2013-08-29 17:50
        
        Sims & evaluation d_labes 2013-08-30 09:16
        
        Sims & evaluation ElMaestro 2013-08-31 14:11
        
        Evaluation subtleties d_labes 2013-08-31 17:20