Research Articles
CLIA vs FDA for IHC Assays: A Definitive Guide for Research and Diagnostic Compliance
This article provides a comprehensive analysis of CLIA and FDA regulatory requirements for immunohistochemistry (IHC) assays, tailored for researchers, scientists, and drug development professionals.
Navigating the Regulatory Shift: A Comprehensive Guide to CLIA Validation vs. IVDR for IHC Assays in Research and Drug Development
This article provides a critical comparison between the Clinical Laboratory Improvement Amendments (CLIA) validation framework, predominant in the US, and the In Vitro Diagnostic Regulation (IVDR), the new EU regulatory...
A Practical Guide to CLIA Validation for IHC Assays: From Design to Compliance
This article provides a comprehensive, step-by-step framework for designing and executing a robust CLIA validation study for immunohistochemistry (IHC) assays.
Navigating CLIA Validation for IHC Predictive Biomarkers: A Comprehensive Guide for Precision Medicine
This article provides a detailed roadmap for researchers and drug development professionals to successfully validate immunohistochemistry (IHC) predictive markers under Clinical Laboratory Improvement Amendments (CLIA) requirements.
Navigating CLIA Validation for IHC Assays: A Complete Guide for Research and Development
This comprehensive guide demystifies the process of achieving CLIA (Clinical Laboratory Improvement Amendments) validation for Immunohistochemistry (IHC) assays.
Beyond Formalin: A Practical Guide to CLIA Validation for IHC Assays on Alternative Fixatives
This comprehensive guide addresses the critical need for validating immunohistochemistry (IHC) assays on alternative tissue fixatives under CLIA (Clinical Laboratory Improvement Amendments) regulations.
Navigating CLIA Compliance: A Complete Guide to IHC Assay Revalidation for Clinical Labs
This comprehensive guide demystifies CLIA regulations for Immunohistochemistry (IHC) assay revalidation.
Concordance and Discordance in HER2 Testing: A Comprehensive Analysis of CISH vs FISH Methodologies for Clinical Research
This article provides a critical review and structured analysis of Chromogenic In Situ Hybridization (CISH) and Fluorescence In Situ Hybridization (FISH) concordance studies for HER2 status assessment in breast cancer...
The Dynamics of CDR Loop Flexibility: How Structural Plasticity Drives Antibody-Antigen Recognition and Enables Next-Generation Therapeutics
This article provides a comprehensive review of Complementarity-Determining Region (CDR) loop flexibility and its critical role in antibody-antigen binding for researchers and drug developers.
Complete Guide to CAP IHC Validation: A Step-by-Step Protocol for Researchers & Diagnostic Labs
This comprehensive guide details the College of American Pathologists (CAP) guidelines for Immunohistochemistry (IHC) test validation, tailored for researchers, scientists, and drug development professionals.