European Bioanalysis Forum and the way forward towards harmonized regulations

Bioanalysis

Volumn 1, Issue 5, 2009, Pages 873-875

  Lausecker, Berthold ^a   Van Amsterdam, Peter ^b   Brudny Kloeppel, Margarete ^c   Luedtke, Silke ^d   Timmerman, Philip ^e  

^a F HOFFMANN LA ROCHE LTD   (Switzerland)

^b Solvay Pharmaceuticals   (India)

^c BAYER PHARMA AG   (Germany)

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

^e Johnson and Johnson ^*  (India)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

CHEMICAL ANALYSIS; EDITORIAL; EUROPE; HUMAN; SOCIAL CONTROL; STANDARD;

CHEMISTRY TECHNIQUES, ANALYTICAL; EUROPE; HUMANS; PHARMACEUTICAL PREPARATIONS; SOCIAL CONTROL, FORMAL;

EID: 79953245901     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.09.96     Document Type: Editorial

References (8)

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2. Shah V P, Midha KK, Findlay JW et al. Bioanalytical method validation-a revisit with a decade of progress. Pharm. Res. 17, 1551-1557 (2000).
3. US FDA. Guidance for Industry: Bioanalytical Method Validation. Rockville, MD, US Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, USA (2001).
4. DeSilva B, Smith W, Weiner R et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. 20, 1885-1900 (2003).
5. Viswanathan CT, Bansal S, Booth B et al. Bioanalytical method validation and implementation: best practices for chromatographic and ligand binding assays. AAPS J. 9(1), E30-E38 (2007).
6. EMEA. Concept paper/recommendations on the need for a (CHMP) guideline on the validation of bioanalytical methods. EMEA/CHMP/EWP/531305/2008 (2008).
7. EMEA. Investigation of bioequivalence. CHMP/EWP/QWP/1401/98 (2008).
8. EMEA. Guidance for the evaluation of control samples in non-clinical safety studies: checking for contamination with test substance. CPMP/SWP/1094/04 (2005).