Bioequivalence and Bioavailability Forum • method development for bioequivalance study

method development for bioequivalance study [Bioanalytics]

posted by ElMaestro – Denmark, 2010-07-19 01:22 (5805 d 22:42 ago) – Posting: # 5652
Views: 5,735

Hi sadia.amin,

❝ i need guidance for method development for HPLC study of plasma, i have

❝ not started my research yet and have many question in my mind. For HPLC

❝ study can i use the methods given in pharmacopoeia or i have to develop my

❝ own method, and is that easy to develop a method?

You are free to choose whatever method you like, it "just" needs to be validated.
A pharmacopoeial entry may give you a good hint about an appropriate method, but the biological complexity is usually not reflected in it. If I were you my priority list would be:

1. Name the compound and ask in this forum if other have experience with it and what method they use.
2. Literature searches (including animal studies).
3. Ask at your API source.
4. Get inspiration from pharmacopoeias.

Best regards
EM.

—
Pass or fail!
ElMaestro

Complete thread:

method development for bioequivalance study sadia.amin 2010-07-18 22:38 [Bioanalytics]
- method development for bioequivalance studyElMaestro 2010-07-18 23:22
  - method development for bioequivalance study sadia.amin 2010-07-26 13:43
    - cefaclor or cefixime BE Helmut 2010-07-26 14:29
      - cefaclor or cefixime BE sadia.amin 2010-07-26 20:26
        
        BE basics Helmut 2010-07-27 01:43
- method development for bioequivalance study Jagdish Bairagi 2010-07-27 16:18
  - method development for bioequivalance study Helmut 2010-07-27 16:39