Recommendations for validation of LC-MS/MS bioanalytical methods for protein biotherapeutics.

Jenkins, Rand; Duggan, Jeffrey X; Aubry, Anne-Françoise; Zeng, Jianing; Lee, Jean W; Cojocaru, Laura; Dufield, Dawn; Garofolo, Fabio; Kaur, Surinder; Schultz, Gary A; Xu, Keyang; Yang, Ziping; Yu, John; Zhang, Yan J; Vazvaei, Faye

Jenkins, Rand; Duggan, Jeffrey X; Aubry, Anne-Françoise; Zeng, Jianing; Lee, Jean W; Cojocaru, Laura; Dufield, Dawn; Garofolo, Fabio; Kaur, Surinder; Schultz, Gary A; Xu, Keyang; Yang, Ziping; Yu, John; Zhang, Yan J; Vazvaei, Faye.

Affiliation

Jenkins R; Chromatographic Sciences, PPD Bioanalytical Laboratories, 2244 Dabney Road, Richmond, Virginia, 23230, USA.

AAPS J ; 17(1): 1-16, 2015 Jan.

Article in En | MEDLINE | ID: mdl-25392238

Subject(s)

Chromatography, Liquid/methods; Proteins/analysis; Tandem Mass Spectrometry/methods; Animals; Canada; Humans; United States; Validation Studies as Topic

Fulltext

XML

PubMed Links

Search on Google

Full text: 1 Database: MEDLINE Main subject: Proteins / Chromatography, Liquid / Tandem Mass Spectrometry Type of study: Guideline / Qualitative_research Limits: Animals / Humans Country/Region as subject: America do norte Language: En Year: 2015 Type: Article

Fulltext

XML

PubMed Links

Search on Google