Large Molecule Run Acceptance: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

The L1 Global Harmonization Team provides recommendations specifically for run acceptance of ligand binding methods used in bioanalysis of macromolecules in support of pharmacokinetics. The team focused on standard curve calibrators and quality controls for use in both pre-study validation and in-st...

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Hlavní autoři: Kelley, Marian, Beaver, Christopher, Stevenson, Lauren F., Bamford, Ross, Gegwich, Paula, Katsuhiko, Yamamoto, Li, Dongbei, Little, Samantha, Muruganandam, Arumugam, Stoellner, Daniela, Trivedi, Ravi Kumar
Médium: Artigo
Jazyk:Inglês
Vydáno: Springer US 2014
Témata:
White Paper
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC3933574/
https://ncbi.nlm.nih.gov/pubmed/24395373
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-013-9553-8
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