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...

Deskribapen osoa

Gorde:
Xehetasun bibliografikoak
Egile Nagusiak: Kelley, Marian, Beaver, Christopher, Stevenson, Lauren F., Bamford, Ross, Gegwich, Paula, Katsuhiko, Yamamoto, Li, Dongbei, Little, Samantha, Muruganandam, Arumugam, Stoellner, Daniela, Trivedi, Ravi Kumar
Formatua: Artigo
Hizkuntza:Inglês
Argitaratua: Springer US 2014
Gaiak:
White Paper
Sarrera elektronikoa: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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