Bioequivalence and Bioavailability Forum

tmax, nonparametrics [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2008-10-14 13:29 (6091 d 12:40 ago) – Posting: # 2528
Views: 23,701

Dear D. Labes!

❝ […] But what can we do if a regulative authority is missing all the discussions and results in the scientific community?

Everybody should actively challenge the draft at conferences, use personal contacts with regulators, and send comments until Jan 31^st, 2009 to [email protected] using this M$-Word-template.

❝ Our sponsors in most cases take guidances not as such but as unalterable law! They dont like to have deficiency letters only because a letter of a guidance was not followed strictly.

Yes, I know… I think it's part of our business to explain to them, that they should act right now. Once the guideline is finalized, they will only have two options - if deviating from the guideline, come up with a justification beforehand (probably also aiming for a scientific advice) and cross their fingers, or strictly follow the track (which will result in ridiculous sample sizes, more studies in patients, etc.)…

❝ I suspect "We HAVE to be just sheep". Meanwhile I will try to adapt to eat hey .

You will have to grow a lot of gut since the ratio of lengths (body/gut) is 1:6 for man and 1:24 for sheep. You should change your nutrition to vegetables only, otherwise you will suffer from putrefaction of meat.

P.S.:
More than two thirds of publications in ‘Biometrics’ and ‘Statistics in Medicine’ are based on Bayesian and/or Nonparametric methods.
I’m really glad that regulators in the BE-fields rely solely on methods based on the t-distribution, introduced exactly 100 years ago by William S. Gosset, aka “A Student of Statistics” (1876-1937).

—
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:

• Critical review of EU BE guideline (Rev.1) Helmut 2008-08-22 14:30 [Regulatives / Guidelines] 
  • Critical review of EU BE guideline (Rev.1) d_labes 2008-08-22 15:42
    • Critical review of EU BE guideline (Rev.1) Helmut 2008-08-23 02:02
      • Critical review of EU BE guideline (Rev.1) d_labes 2008-08-25 09:14
        • Variations Helmut 2008-08-25 11:06
  • Critical review of EU BE guideline (Rev.1) Jaime_R 2008-08-23 16:47
    • Critical review of EU BE guideline (Rev.1) Ravi 2008-08-25 08:19
      • Two Stage Design Helmut 2008-08-25 11:43
        • Two Stage Design JPL 2008-08-28 09:44
          • Two Stage Design Helmut 2008-08-28 11:50
            • Two Stage Design d_labes 2008-08-28 12:09
            • Sequential Design Helmut 2008-11-05 13:22
    • Critical review of EU BE guideline (Rev.1) banusunman 2008-08-26 16:56
      • Washout Helmut 2008-10-15 16:02
  • Critical review of EU BE guideline (Rev.1) d_labes 2008-08-25 09:49
    • Critical review of EU BE guideline (Rev.1) Helmut 2008-08-25 12:11
      • Critical review of EU BE guideline (Rev.1) d_labes 2008-08-25 13:03
      • Urban legend? Helmut 2008-11-21 16:06
        • Urban legend? d_labes 2008-11-24 15:06
  • Critical review of EU BE guideline (Rev.1) d_labes 2008-08-25 11:16
  • Critical review of EU BE guideline (Rev.1), tmax, MRT, LZ d_labes 2008-08-25 11:32
    • Critical review of EU BE guideline (Rev.1), tmax, MRT, LZ Helmut 2008-08-25 13:10
    • tmax, nonparametrics Helmut 2008-10-13 15:38
      • tmax, nonparametrics d_labes 2008-10-14 08:33
        • tmax, nonparametricsHelmut 2008-10-14 11:29
        • tmax, Canadian approach Helmut 2008-11-21 15:41
          • tmax, Canadian approach d_labes 2008-11-24 13:53
            • Early exposure, Canadian approach: GMR only! Helmut 2009-02-08 00:44
              • Early exposure, Canadian approach: GMR only! d_labes 2009-02-09 08:50
          • tmax; another example Helmut 2008-12-25 15:59
  • Automatic integration janmacek 2008-08-27 12:21
    • Automatic integration Ohlbe 2008-08-27 14:49
      • Manual reintegration! H_Rotter 2008-08-28 11:28
        • Manual reintegration! ElMaestro 2008-08-28 12:44
  • Subject accountability, Proc MIXED or equivalent d_labes 2008-09-02 11:13
    • Subject accountability, Proc MIXED or equivalent Ohlbe 2008-09-02 15:20
      • Subject accountability, Proc MIXED or equivalent d_labes 2008-09-02 16:30
  • partial AUC, early exposure d_labes 2008-09-03 08:35
  • HVDs? Helmut 2008-09-23 12:52
    • HVDs? d_labes 2008-09-23 14:20
    • HVDs? Helmut 2009-01-20 14:33
    • E.g., omeprazole Helmut 2009-03-06 17:21
  • BCS-based Biowaiver Helmut 2008-09-25 15:48
    • Dissolution update Helmut 2008-10-13 12:43
  • EUFEPS workshop Helmut 2008-12-23 17:03