Bioequivalence and Bioavailability Forum • What’s the problem?

What’s the problem? [Bioanalytics]

posted by Helmut – Vienna, Austria, 2012-02-11 13:59 (4858 d 23:08 ago) – Posting: # 8109
Views: 7,171

Dear Auditor!

❝ you mean to say that up to some of the extent variation in nominal concentration is accepted.

Yes.

❝ In India we always tried to give appropriate dilution to the taken weight to get the concentration of nominal within the validated range.

How to you do that (“appropriate dilution”)?

❝ Might be regulatory having different approach while auditing data generated in India and over sea's.

Can you give an example of regulatory problems by the CDSCO/DCGI?

❝ We believes that if some thing is not cover by establish calibration curve we have to generate some supporting data for the same. And we believe that such kind of issue will not add any value to establish validated range.

Believes cannot be challenged. Have nothing to do with science.

❝ Still i am not clear about reply given by you.

Example:

In validation you weighed in 20.1 mg and in the study 19.9 mg.
Deviation –1%: no problem.
In validation you weighed in 19.9 mg and in the study 20.1 mg.
Deviation +1%: problem. Why?

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Helmut Schütz

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Complete thread:

Extrapolation of Calibration Curve auditor 2012-02-10 06:45
- Exact weight Ohlbe 2012-02-10 12:05
  - Exact weight auditor 2012-02-10 15:54
    - Exact weight: impossible Helmut 2012-02-10 17:33
    - Exact weight Ohlbe 2012-02-10 18:10
      - Exact weight Helmut 2012-02-10 19:15
        
        Exact weight auditor 2012-02-11 06:49
        
        What’s the problem?Helmut 2012-02-11 12:59
        
        What’s the problem? ElMaestro 2012-02-11 20:20
        What’s the problem? auditor 2012-02-13 05:35
        
        Adjusted dilution? Helmut 2012-02-13 13:29
        What’s the problem? Aceto81 2012-02-16 10:50
        
        What’s the problem? auditor 2012-02-16 12:23
        ±5%? Helmut 2012-02-16 13:24
        
        weight pharmino 2012-02-17 21:24
        
        API/formulation Helmut 2012-02-18 13:34