Bioequivalence and Bioavailability Forum • Use of pro-drug instead of active

Use of pro-drug instead of active [Bioanalytics]

posted by Ionsource – Pakistan, 2012-08-04 15:07 (4684 d 05:48 ago) – Posting: # 9036
Views: 5,361

Hi everybody

Is it appropriate to use Candesartan cilexitil instead of candesartan (unesterified) to develop analytical method for candesartan. I personally believe it shouldn't be done but I got confused when I had read in FDA guidance the following text
"If possible, the reference standard should be identical to the analyte. When this is not possible, an established chemical form (free base or acid, salt or ester) of known purity can be used". how could an ester be used instead?

Please somebody let me know. thanks

Complete thread:

Use of pro-drug instead of activeIonsource 2012-08-04 13:07
- Use of pro-drug instead of active Helmut 2012-08-05 01:26
  - Use of pro-drug instead of active Ionsource 2012-08-05 14:17
    - Sources of reference standards Helmut 2012-08-05 15:35
      - Sources of reference standards Ionsource 2012-08-06 06:27
  - FDA guidance Ohlbe 2012-08-08 23:53