Guideline for the validation of biological assay methods

S.T.P. Pharma Pratiques

Volumn 15, Issue 5, 2005, Pages 364-383

  Ramond, Benoît ^a   Gaillandre, A ^b   Gibelin, Nicole ^c   Maignan, Nicole ^d   Michalski, Catherine ^f   Nabet, Pascale ^e   Niewiaski, Claude ^g   Poirault, Didier ^h   Poirier, Bertrand ⁱ   Rigal, H ^g  

^a Sanofi Aventis   (United States)

^b LFB   (France)

^c SANOFI PASTEUR   (France)

^d Cebac   (France)

^e SANOFI   (France)

^f LFB   (France)

^g Merial ^*

^h BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

ⁱ AFSSAPS   (France)

Author keywords

Biological methods; Drug product; Drug substance; European Union; ICH; Statistics; Validation

Indexed keywords

ACCURACY; ANALYTIC METHOD; BIOASSAY; BIOTECHNOLOGY; PRACTICE GUIDELINE; QUANTITATIVE ANALYSIS; REPRODUCIBILITY; REVIEW; SENSITIVITY AND SPECIFICITY; VALIDATION PROCESS;

EID: 32244438179     PISSN: 11571497     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (5)

1. International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use: Q2A Text on Validation of Analytical Procedures CPMP/ICH/381/95. Q2B Validation of Analytical Procedures: Methodology CPMP/ICH/281/95.
2. Guide de validation analytique. SFSTP committee report. I. Methodology - STP Pharma Pratiques 2 (4) 205-226, 1992.
3. Guide de validation analytique. SFSTP committee report II. Examples - STP Pharma Pratiques 2 (4) 227-239, 1992.
4. Substances biologiques de référence. SFSTP committee report. STP Pharma Pratiques 6 (2) 99-105, 1996.
5. The statistical analysis of experimental data. J. Mandel, Dover, New York, 1964.