Research Articles
Navigating the IVD Regulatory Divide: A Strategic Comparison of US FDA and EU IVDR Requirements
This article provides a comprehensive analysis for researchers, scientists, and drug development professionals on the evolving regulatory landscapes for In Vitro Diagnostics (IVDs) in the United States and European Union.
Spike and Recovery Experiments for ELISA Validation: A Complete Guide to Principles, Methods, and Troubleshooting
This comprehensive guide details the critical role of spike and recovery experiments in validating Enzyme-Linked Immunosorbent Assay (ELISA) accuracy and reliability for researchers, scientists, and drug development professionals.
Antibody Validation for Immunohistochemistry: A Comprehensive Guide to Protocols, Pitfalls, and Best Practices
This article provides a comprehensive guide to antibody validation protocols for immunohistochemistry (IHC), tailored for researchers, scientists, and drug development professionals.
Navigating IHC Assay Validation: A Comprehensive Guide to CLIA Requirements and Best Practices
This article provides researchers, scientists, and drug development professionals with a current and actionable guide to Immunohistochemistry (IHC) assay validation within the Clinical Laboratory Improvement Amendments (CLIA) framework.
ELISA vs Flow Cytometry: A Comprehensive Guide to Immunochemical Methods for Biomedical Research
This guide provides researchers, scientists, and drug development professionals with a thorough exploration of two cornerstone immunochemical techniques: Enzyme-Linked Immunosorbent Assay (ELISA) and Flow Cytometry.
Antigen-Antibody Reaction Specificity: From Molecular Foundations to Research Validation
This article provides a comprehensive exploration of antigen-antibody reaction specificity, tailored for researchers, scientists, and drug development professionals.
Cytokines and Chemokines: Orchestrators of Immunity and Pioneering Targets in Disease Therapy
This article provides a comprehensive exploration of cytokines and chemokines, the critical signaling proteins that orchestrate immune responses.
Navigating IHC Assay Commercialization: A 2025 Guide to Regulatory Strategy and Global Market Success
This article provides a comprehensive roadmap for researchers, scientists, and drug development professionals navigating the complex regulatory and commercial landscape for Immunohistochemistry (IHC) assays.
Navigating ISO 15189: A Comprehensive Guide to IHC Assay Validation for Reliable Diagnostics
This article provides researchers, scientists, and drug development professionals with a detailed roadmap for implementing ISO 15189 standards in Immunohistochemistry (IHC) assay validation.
Polymer-Based vs. Biotin-Based Detection: A Comprehensive Guide for Biomedical Research and Diagnostics
This article provides a thorough comparison of polymer-based and biotin-based detection systems in immunohistochemistry (IHC), tailored for researchers, scientists, and drug development professionals.