Large molecule specific assay operation: recommendation for best practices and harmonization from the global bioanalysis consortium harmonization team

Autor:	Heather Myler, Lauren Stevenson, Boris Gorovits, Karolina Österlund, Mario Dominguez, Yoshiyuki Minamide, Clare Kingsley, Marian Kelley, Arumugam Muruganandam
Rok vydání:	2013
Předmět:	Analyte Bioanalysis Risk analysis (engineering) Computer science Best practice Practice Guidelines as Topic Pharmaceutical Science Proteins White Paper Harmonization Validation Studies as Topic Simulation Chemistry Techniques Analytical
Zdroj:	The AAPS journal. 16(1)
ISSN:	1550-7416
Popis:	The L2 Global Harmonization Team on large molecule specific assay operation for protein bioanalysis in support of pharmacokinetics focused on the following topics: setting up a balanced validation design, specificity testing, selectivity testing, dilutional linearity, hook effect, parallelism, and testing of robustness and ruggedness. The team additionally considered the impact of lipemia, hemolysis, and the presence of endogenous analyte on selectivity assessments as well as the occurrence of hook effect in study samples when no hook effect had been observed during pre-study validation.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::809142bf9ef35d234bc0782039ad192f https://pubmed.ncbi.nlm.nih.gov/24242296 Zobrazit plný text záznamu Full text from SpringerLink