A Case Study for Critical Reagent Qualification for Ligand Binding Assays Using Equivalence Test Methodology

Qualifying critical reagents in ligand binding assays by parallel testing of current and candidate reagent lots is recommended by regulatory agencies and industry groups, but specific guidance on the format of reagent qualification experiments is limited. Equivalence testing is a statistically sound...

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Veröffentlicht in:	The AAPS journal 2023-09, Vol.25 (5), p.89-89, Article 89
Hauptverfasser:	Niemuth, Nancy A., Triplett, Cheryl A., Anderson, Michael S., Sankovich, Karen A., Rudge, Thomas L.
Format:	Artikel
Sprache:	eng
Schlagworte:	Analysis Biochemistry Biomedical and Life Sciences Biomedicine Biotechnology Case studies Chemical tests and reagents Independent regulatory commissions Medical screening Methods Pharmacology/Toxicology Pharmacy Protocols in Pharmaceutical Sciences
Online-Zugang:	Volltext
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