Bioequivalence and Bioavailability Forum • weight

weight [Bioanalytics]

posted by pharmino – 2012-02-17 22:24 (4856 d 04:32 ago) – Posting: # 8141
Views: 6,970

Hi all!

First of all: nice page.

2nd: By the weight... A technologist colleague asked me about her doubts about the interpretation of the GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE (sorry for the caps, I was lazy not to paste it as it was written on the front page). So the guideline states in the c/i biowaiver criterion: "the amount of the active substance(s) is less than 5 % of the tablet core weight, the weight of the capsule content".

Question is: the weight of the salt counts (I guess this is the case) or only the weight of the active cation? Further formulation strategy depends on the answer. And yes, I'm quite a newbie in this field.

Thanks.

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
        
        weightpharmino 2012-02-17 21:24
        
        API/formulation Helmut 2012-02-18 13:34