Bioequivalence and Bioavailability Forum • Validity of Plasma, Serum and Blood after collection

Validity of Plasma, Serum and Blood after collection [Regulatives / Guidelines]

posted by paulhurleyuk – NE UK, 2010-07-15 14:46 (5809 d 11:12 ago) – Posting: # 5636
Views: 2,789

❝ i would like to know how do they fix validity date for the respective samples (i.e. valid upto).

Typically Analyte Stability in the sample matrix is proven during method validation. Refer to some fo the many guidelines in the guidelines area

Validation of Analytical Procedures – Text and Methodology; Q2(R1): step 4, Nov 2005
Concept Paper/Recommendations on the Need for a (CHMP) Guideline on the Validation of Bioanalytical Methods: Dec 2008 (PDF52KB)
Validation of Analytical Procedures. Definition and Terminology: Jun 1994 (PDF31KB), Methodology: Jun 1997 (PDF50KB)
Bioanalytical Method Validation: May 2001 (PDF63KB)

Regards,

Paul.

Complete thread:

Validity of Plasma, Serum and Blood after collection ramesh_7779 2010-07-15 08:23 [Regulatives / Guidelines]
- Validity of Plasma, Serum and Blood after collection Ohlbe 2010-07-15 10:24
  - Validity of Plasma, Serum and Blood after collection ramesh_7779 2010-07-15 11:58
    - Validity of Plasma, Serum and Blood after collectionpaulhurleyuk 2010-07-15 12:46
    - Validity of Plasma, Serum and Blood after collection Ohlbe 2010-07-15 15:06

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