A carregar...

Assessment of Incurred Sample Reanalysis for Macromolecules to Evaluate Bioanalytical Method Robustness: Effects from Imprecision

Incurred sample reanalysis (ISR) is recommended by regulatory agencies to demonstrate reproducibility of validated methods and provide confidence that methods used in pharmacokinetic and toxicokinetic assessments give reproducible results. For macromolecules to pass ISR, regulatory recommendations r...

ver descrição completa

Na minha lista:
Detalhes bibliográficos
Main Authors: Thway, Theingi M., Eschenberg, Michael, Calamba, Dominador, Macaraeg, Chris, Ma, Mark, DeSilva, Binodh
Formato: Artigo
Idioma:Inglês
Publicado em: Springer US 2011
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3085709/
https://ncbi.nlm.nih.gov/pubmed/21461973
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-011-9271-z
Tags: Adicionar Tag
Sem tags, seja o primeiro a adicionar uma tag!