Bioequivalence and Bioavailability Forum • My lack of understanding

My lack of understanding [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2010-06-01 18:13 (5497 d 01:00 ago) – Posting: # 5407
Views: 17,230

Dear KR,

❝ Would you please provide some more clarification/explaination to conduct the pharmacodynamic and statistical analysis considering the practical applicability in mind ?

There's an old Chinese proverb that goes like this:
If in doubt about BE-statistics, ask d_labes.

As a pure amateur from the lowest rank of scum, here's what I imagine would be a possible approach:
Your starting point is a dataset consisting of n subjects. On each subject, you have 4 pharmacodynamic data points: Run-in, test, ref-lo, ref-hi. Then...

Put all numbers 1...n into a hat.
Ask a NLYW to pull out one of these numbers n times. Everytime she pulls out a number she notes the sampled number down and puts the number back in the hat.
Once she has done it you take the piece of paper she has written which contains n numbers of which some might be identical. With this piece of papers you construct your sample dataset as Run-in, test, ref-lo, and ref-hi for each subject number she pulled out of the hat (remember: one subject's data might occur more than once in the sampled dataset).
On this sample dataset you fit your ref data to the model in the guideline.
Knowing the nominal strength of the test, you can now calculate a relative potency from the sample. You write down that reltive potency.
You give the NLYW a new and blank piece of paper, sharpen her pencil, and steps 2...5 are now repeated a lot of times. The more the better. I do not know the minimum, but I'd put the lower limit at 500 because FDA has used that limit in other bootstrap applications.
You now have 500 (or whatever) recordings on relative potency. Now you go to the library and figure out the BCA from those 500 (or whatever) numbers.
You submkit your data to the Organic Grocery Deals and await approval.

Note: This should be done using validated systems. This implies that the NLYW and her interaction with the hat should be qualified.

Best regards
EM.

—
Pass or fail!
ElMaestro

Complete thread:

Orlistat Bioequivalence KR 2010-04-23 06:14 [Regulatives / Guidelines]
- To Abreviate or not to Abreviate d_labes 2010-04-23 09:28
  - What was really meant ElMaestro 2010-04-23 09:50
    - OGD Guidance Helmut 2010-04-23 12:42
  - To Abreviate or not to Abreviate KR 2010-04-23 15:01
    - Calm and serene d_labes 2010-04-23 15:47
    - To Abreviate or not to Abreviate ElMaestro 2010-04-24 08:16
      - To Abreviate or not to Abreviate KR 2010-04-26 06:03
        
        To Abreviate or not to Abreviate GSTATS 2010-05-27 18:30
        
        My lack of understanding ElMaestro 2010-05-28 00:54
        
        My lack of understanding GSTATS 2010-05-28 17:03
        
        My lack of understanding ElMaestro 2010-05-29 03:32
        
        My lack of understanding GSTATS 2010-05-29 05:28
        
        My lack of understanding KR 2010-05-31 08:51
        
        My lack of understandingElMaestro 2010-06-01 16:13
        
        Calculation sangeeta 2011-11-29 17:58
        
        Calculation ElMaestro 2011-11-29 18:09
        
        Calculation sangeeta 2011-11-29 18:30
        
        Calculation ElMaestro 2011-11-30 11:35