Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 1 de 1
Filter
Add more filters










Database
Language
Publication year range
1.
AAPS J ; 16(2): 221-5, 2014 Mar.
Article in English | MEDLINE | ID: mdl-24395373

ABSTRACT

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-study sample analysis, including their preparation and acceptance criteria. The team also considered standard curve editing and the concept of total error.


Subject(s)
Macromolecular Substances/analysis , Practice Guidelines as Topic , Validation Studies as Topic , Quality Control
SELECTION OF CITATIONS
SEARCH DETAIL
...