Bioequivalence and Bioavailability Forum • Reg: Partial method validation

Reg: Partial method validation [Bioanalytics]

posted by moblak – 2009-10-13 06:02 (6099 d 00:47 ago) – Posting: # 4345
Views: 5,770

Dear Shweta

❝ The calibration range has been changed from 50ng/mL-5000ng/mL to 10ng/mL - 5000ng/mL.

❝ Isn't there need of carry over and more P&A experiment?

IMHO you should also perform all stability experiments at the new (lower) QCL level.

Regards
Marko

Complete thread:

Reg: Partial method validation shweta 2009-10-08 13:37 [Bioanalytics]
- Reg: Partial method validation Ohlbe 2009-10-08 15:50
  - Reg: Partial method validation shweta 2009-10-09 11:07
- Reg: Partial method validationmoblak 2009-10-13 04:02
  - Reg: Partial method validation shweta 2009-10-14 09:46
    - Reg: Partial method validation Helmut 2009-10-14 12:44

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