Recommendations for Validation of LC-MS/MS Bioanalytical Methods for Protein Biotherapeutics

AAPS Journal

Volumn 17, Issue 1, 2015, Pages 1-16

  Jenkins, Rand ^a   Duggan, Jeffrey X ^b   Aubry, Anne Françoise ^c   Zeng, Jianing ^c   Lee, Jean W ^d   Cojocaru, Laura ^e   Dufield, Dawn ^f   Garofolo, Fabio ^g   Kaur, Surinder ^h   Schultz, Gary A ⁱ   Xu, Keyang ^h   Yang, Ziping ^j   Yu, John ^b   Zhang, Yan J ^c   Vazvaei, Faye ^k  

^a Chromatographic Sciences PPD Bioanalytical Laboratories   (United States)

^b BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^c BRISTOL MYERS SQUIBB   (United States)

^d SAFER Systems LLC   (United States)

^e Tandem Labs   (United States)

^f Pfizer Global Research and Development   (United States)

^g Warnex Bioanalytical Services   (Canada)

^h GENENTECH INC   (United States)

ⁱ IQVIA   (United States)

^j NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH   (United States)

^k Roche Innovation Center New York   (United States)

more..

Author keywords

affinity capture mass spectrometry; industry white paper; method validation; protein LC MS MS quantification; regulated bioanalysis

Indexed keywords

PROTEIN;

ANIMAL; CANADA; HUMAN; LIQUID CHROMATOGRAPHY; PROCEDURES; TANDEM MASS SPECTROMETRY; UNITED STATES; VALIDATION STUDY;

ANIMALS; CANADA; CHROMATOGRAPHY, LIQUID; HUMANS; PROTEINS; TANDEM MASS SPECTROMETRY; UNITED STATES; VALIDATION STUDIES AS TOPIC;

EID: 84964313903     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-014-9685-5     Document Type: Article

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