Ligand Binding Assay Critical Reagents and Their Stability: Recommendations and Best Practices from the Global Bioanalysis Consortium Harmonization Team
Journal Title: The AAPS Journal - Year 2014, Vol 16, Issue 3
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.
Authors and Affiliations
Lindsay E. King, Esme Farley, Mami Imazato, Jeannine Keefe, Masood Khan, Mark Ma, K. Susanne Pihl, Priya Sriraman
Keywords
Related Articles
- EP ID EP681693
- DOI 10.1208/s12248-014-9583-x
- Views 77
- Downloads 0
Selective and validated spectrophotometric methods for the determination of nicorandil in pharmaceutical formulations
Two simple and sensitive validated spectrophotometric methods have been described for the assay of nicorandil in drug formulations. Method A is based on the reaction of the drug with phloroglucinol-sulfanilic acid reagen...
Points to Consider when Establishing Drug Product Specifications for Parenteral Microspheres
Drug product specifications are a critical element of a good control strategy. Parenteral microsphere products are complex dosage forms, requiring careful development of test methods and acceptance criteria for the speci...
The Role of Quantitative Pharmacology in an Academic Translational Research Environment
Translational research is generally described as the application of basic science discoveries to the treatment or prevention of disease or injury. Its value is usually determined based on the likelihood that exploratory...
International Veterinary Bioequivalence Guideline Similarities and Differences Between Australia, Canada, Europe, Japan, New Zealand and the United States
Considering the diversity in physiology between species and the numerous dosage forms that exist in veterinary drug products, there are numerous complex issues that arise from the development and regulation of veterinary...
Engineered Nanoparticulate Drug Delivery Systems: The Next Frontier for Oral Administration?
For the past few decades, there has been a considerable research interest in the area of oral drug delivery using nanoparticle (NP) delivery systems as carriers. Oral NPs have been used as a physical approach to improve...