Bioequivalence and Bioavailability Forum • What’s the problem?

What’s the problem? [Bioanalytics]

posted by auditor – India, 2012-02-13 06:35 (5249 d 15:45 ago) – Posting: # 8112
Views: 8,592

❝ ❝ 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”)?

in that we are targeting required concentration. After acheiving that concentration we prepare remaining level of the curve by serial dilution. this way we always prepare all the level within the establish calibration curve.

❝ ❝ 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?

I am no talking about CDSCO/ DCGI. I am talking about US FDA. In one of the meeting we have discuss this point and they suggest to have all the level within the establish calibration curve. (Sorry i can not give name of the agency inspector)

❝ Deviation –1%: no problem.

this will allow us to prepare calibration curve level within the range.

❝ In validation you weighed in 19.9 mg and in the study 20.1 mg.

❝ Deviation +1%: problem. Why?

We do not worry about +1% deviation. as we are adjusting concentration by dilution.

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