相关参考文献
注意：仅列出部分参考文献，下载原文获取全部文献信息。Characterization of critical reagents in ligand-binding assays: enabling robust bioanalytical methods and lifecycle management
Brian J. Geist et al.
BIOANALYSIS (2013)
The European Bioanalysis Forum community's evaluation, interpretation and implementation of the European Medicines Agency guideline on Bioanalytical Method Validation
Peter van Amsterdam et al.
BIOANALYSIS (2013)
Ligand Binding Assays in the 21st Century Laboratory: Recommendations for Characterization and Supply of Critical Reagents
Denise M. O'Hara et al.
AAPS JOURNAL (2012)
Validation and life-cycle management of a quantitative ligand-binding assay for the measurement of Nulojix®, a CTLA-4-Fc fusion protein, in renal and liver transplant patients
Heather A. Myler et al.
BIOANALYSIS (2012)
Commutability Limitations Influence Quality Control Results with Different Reagent Lots
W. Greg Miller et al.
CLINICAL CHEMISTRY (2011)
Stabilization of a monoclonal antibody during purification and formulation by addition of basic amino acid excipients
Robert J. Falconer et al.
JOURNAL OF CHEMICAL TECHNOLOGY AND BIOTECHNOLOGY (2011)
Quality requirements for critical assay reagents used in bioanalysis of therapeutic proteins: what bioanalysts should know about their reagents
Roland F. Staack et al.
BIOANALYSIS (2011)
Role of Protein Stabilizers on the Conformation of the Unfolded State of Cytochrome c and Its Early Folding Kinetics INVESTIGATION AT SINGLE MOLECULAR RESOLUTION
Shubhasis Haldar et al.
JOURNAL OF BIOLOGICAL CHEMISTRY (2010)
Goals of stability evaluation throughout the vaccine life cycle
Philip R. Krause
BIOLOGICALS (2009)
Guidelines on good clinical laboratory practice: Bridging operations between research and clinical research laboratories
J. Ezzelle et al.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2008)
Antimicrobial preservative use in parenteral products: Past and present
Brian K. Meyer et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2007)
Antibody structure, instability, and formulation
Wei Wang et al.
JOURNAL OF PHARMACEUTICAL SCIENCES (2007)
Workshop/conference report - Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays
C. T. Viswanathan et al.
AAPS JOURNAL (2007)
Critical ligand binding reagent Preparation/Selection: When specificity depends on reagents
Bonita Rup et al.
AAPS JOURNAL (2007)
Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples
William Nowatzke et al.
AAPS JOURNAL (2007)
Characterization of a new certified reference material for human Cardiac Troponin I
DM Bunk et al.
CLINICAL CHEMISTRY (2006)
Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
AR Mire-Sluis et al.
JOURNAL OF IMMUNOLOGICAL METHODS (2004)
Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules
B DeSilva et al.
PHARMACEUTICAL RESEARCH (2003)
分享论文
