Request for global harmonization of the guidance for bioanalytical method validation and sample analysis

Bioanalysis

Volumn 2, Issue 4, 2010, Pages 683-

  Timmerman, Philip ^a   Lowes, Steve ^b   Fast, Douglas M ^c   Garofolo, Fabio ^d  

^a European Bioanalysis Forum ^*  (Belgium)

^b American Association of Pharmaceutical Scientists AAPS   (United States)

^c Applied Pharmaceutical Analysis Boston Society for Advanced Therapeutics (APA BSAT)   (United States)

^d Calibration and Validation Group (CVG)   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; AUTHORITY; EUROPE; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HEALTH SERVICE; LETTER; NORTH AMERICA; PRACTICE GUIDELINE; STANDARDIZATION; VALIDATION PROCESS; CHEMICAL ANALYSIS; COOPERATION; INTERNATIONAL COOPERATION; METABOLISM; METHODOLOGY; REPRODUCIBILITY; STANDARD;

DRUG;

CHEMISTRY TECHNIQUES, ANALYTICAL; COOPERATIVE BEHAVIOR; GUIDELINES AS TOPIC; INTERNATIONAL COOPERATION; PHARMACEUTICAL PREPARATIONS; REPRODUCIBILITY OF RESULTS;

EID: 79951893291     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.10.34     Document Type: Letter

References (0)