NDLI: Ligand Binding Assay Critical Reagents and Their Stability: Recommendations and Best Practices from the Global Bioanalysis Consortium Harmonization Team

Content Provider	Springer Nature Link
Author	King, Lindsay E. Farley, Esme Imazato, Mami Keefe, Jeannine Khan, Masood Ma, Mark Pihl, K. Susanne Sriraman, Priya
Copyright Year	2014
Abstract	The L4 Global Harmonization Team on reagents and their stability focused on the management of critical reagents for pharmacokinetic, immunogenicity, and biomarker ligand binding assays. Regulatory guidance recognizes that reagents are important for ligand binding assays but do not address numerous aspects of critical reagent life cycle management. Reagents can be obtained from external vendors or developed internally, but regardless of their source, there are numerous considerations for their reliable long-term use. The authors have identified current best practices and provided recommendations for critical reagent lot changes, stability management, and documentation.
Starting Page	504
Ending Page	515
Page Count	12
File Format	PDF
ISSN	12341234
Journal	The AAPS Journal
Volume Number	16
Issue Number	3
e-ISSN	15507416
Language	English
Publisher	Springer US
Publisher Date	2014-04-01
Publisher Institution	American Association of Pharmaceutical Scientists
Publisher Place	New York
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Pharmacology/Toxicology Biochemistry Biotechnology Pharmacy
Content Type	Text
Resource Type	Article

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Ligand Binding Assay Critical Reagents and Their Stability: Recommendations and Best Practices from the Global Bioanalysis Consortium Harmonization Team