Bioequivalence and Bioavailability Forum • What's the problem?

What's the problem? [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2017-05-17 12:07 – Posting: # 17367
Views: 16,788

Hi DM,

» It would be interesting to study the within study variation for the same compound in the same unit to understand which is the main source of variability. Although I understand the point of El Maestro about assay sensitivity, I don't think that could be pointed as a cause for a study which presented high variability when other studies reported low variability. I understand the approach to highly variable drugs, when the drug is actually highly variable per se and not due to study conduct or assay sensibility.

Then it all comes back to one of Helmut's favourite hobbies, calculation of confidence intervals for variabilities. I think the conclusion generally is that perhaps the drug is highly variable and perhaps it isn't.

—

 if (3) 4 



x=c("Foo", "Bar") 

b=data.frame(x) 

typeof(b[,1]) ##aha, integer?

b[,1]+1 ##then let me add 1

Best regards,
ElMaestro

"(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures." New York Times (ed.), June 9, 2018.

Complete thread:

Highly Variable Drug BE Justification - jag009, 2017-03-20 04:42 [Regulatives / Guidelines]
- Highly Variable Drug BE Justification - ElMaestro, 2017-03-20 06:55
  - Study costs: Replicate vs. 2×2×2 - Helmut, 2017-03-20 13:12
    - Study costs: Replicate seems to be cheaper - VStus, 2017-03-21 12:49
      - Study costs: Replicate seems to be cheaper - Dr_Dan, 2017-03-21 13:06
        
        Study costs: Replicate seems to be cheaper - Helmut, 2017-03-21 14:50
        
        expected power - d_labes, 2017-03-21 15:16
        Doesn't hurt! - VStus, 2017-03-23 14:24
    - Study costs: Replicate vs. 2×2×2 - mahmoud-teaima, 2017-03-23 08:17
    - Study costs: Replicate vs. 2×2×2 - M.tareq, 2017-05-07 21:21
      - Replicate vs. 2×2×2 (ethics?) - Helmut, 2017-05-08 14:21
        
        Replicate vs. 2×2×2 (ethics?) - nobody, 2017-05-08 14:52
        
        Applicability of reference-scaling - Helmut, 2017-05-10 14:10
        
        Replicate vs. 2×2×2 - M.tareq, 2017-05-14 23:04
        
        Replicate vs. 2×2×2 - Helmut, 2017-05-15 19:07
        
        Replicate vs. 2×2×2 - M.tareq, 2017-05-15 21:02
        Regulators view of HVD drugs - DavidManteigas, 2017-05-16 12:41
        
        Regulators view of HVD drugs - Helmut, 2017-05-16 15:01
        What's the problem? - ElMaestro, 2017-05-17 03:30
        
        What's the problem? - nobody, 2017-05-17 07:48
        
        What's the problem? - nobody, 2017-05-17 09:31
        
        What's the problem? - DavidManteigas, 2017-05-17 11:25
        
        What's the problem? - ElMaestro, 2017-05-17 12:07
        
        What's the problem? - kumarnaidu, 2017-07-11 14:43
        
        What's the problem? - ElMaestro, 2017-07-11 14:56

Bioequivalence and Bioavailability Forum 17:02 CET

What's the problem? [Regulatives / Guidelines]

Complete thread: