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Volumn 87, Issue 8, 2015, Pages 4394-4401

Absolute quantification of the total and antidrug antibody-bound concentrations of recombinant human α-glucosidase in human plasma using protein g extraction and LC-MS/MS

Author keywords

[No Author keywords available]

Indexed keywords

EXTRACTION; PATIENT TREATMENT; PROTEINS; RECOMBINANT PROTEINS;

EID: 84928479339     PISSN: 00032700     EISSN: 15206882     Source Type: Journal    
DOI: 10.1021/acs.analchem.5b00169     Document Type: Article
Times cited : (21)

References (24)
  • 16
    • 0003484310 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Veterinary Medicine, Rockville, MD, USA.
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Veterinary Medicine, Guidance for Industry-Bioanalytical Method Validation, Rockville, MD, USA, 2001.
    • (2001) Guidance for Industry - Bioanalytical Method Validation
  • 17
    • 81055146012 scopus 로고    scopus 로고
    • European Medicines Agency - Committee for Medicinal Products for Human Use. European Medicines Agency: London.
    • European Medicines Agency-Committee for Medicinal Products for Human Use. Guideline on bioanalytical method validation; European Medicines Agency: London, 2012.
    • (2012) Guideline on Bioanalytical Method Validation
  • 18
    • 84928478514 scopus 로고    scopus 로고
    • Agência Nacional de Vigilância Sanitária - Brazil. Resolução - RDC No. 27; ANVISA: Brazil.
    • Agência Nacional de Vigilância Sanitária-Brazil. Guide for Validation of Analytical and Bioanalytical Methods; Resolução-RDC No. 27; ANVISA: Brazil, 2012.
    • (2012) Guide for Validation of Analytical and Bioanalytical Methods


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.