Workshop Report: Crystal City V—Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance

AAPS Journal

Volumn 17, Issue 2, 2015, Pages 277-288

  Booth, Brian ^a   Arnold, Mark E ^b   DeSilva, Binodh ^b   Amaravadi, Lakshmi ^c   Dudal, Sherri ^d   Fluhler, Eric ^e   Gorovits, Boris ^e   Haidar, Sam H ^a   Kadavil, John ^a   Lowes, Steve ^f   Nicholson, Robert ^g   Rock, Marie ^h   Skelly, Michael ^a   Stevenson, Lauren ^c   Subramaniam, Sriram ^a   Weiner, Russell ⁱ   Woolf, Eric ⁱ  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b BRISTOL MYERS SQUIBB   (United States)

^c BIOGEN   (United States)

^d F HOFFMANN LA ROCHE LTD   (Switzerland)

^e PFIZER INC   (United States)

^f IQVIA   (United States)

^g Pharmaceutical Product Development   (United States)

^h WIL Research   (United States)

ⁱ MERCK RESEARCH LABORATORIES   (United States)

Author keywords

bioanalytical method validation; Crystal City V; FDA guidance

Indexed keywords

ANTIBODY; BIOLOGICAL MARKER;

ACCURACY; ANALYTIC METHOD; ARTICLE; CALIBRATION; CHROMATOGRAPHY; DOCUMENTATION; DRUG CONJUGATION; FOOD AND DRUG ADMINISTRATION; LIMIT OF QUANTITATION; OUTCOME ASSESSMENT; PRACTICE GUIDELINE; PROCESS DEVELOPMENT; QUALITY CONTROL; QUANTITATIVE ANALYSIS; RECEPTOR BINDING ASSAY; UNITED STATES; VALIDATION PROCESS; WORKSHOP; BIOASSAY; GOVERNMENT REGULATION; HUMAN; PROCEDURES; STANDARDS; VALIDATION STUDY;

BIOLOGICAL ASSAY; BIOMARKERS; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VALIDATION STUDIES AS TOPIC;

EID: 84925850888     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-014-9696-2     Document Type: Article

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