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Implementing ICH M10: Finally, a Harmonized Bioanalytical Method Validation Guidance
Until recently, different global regulatory agencies had varying requirements for validating bioanalytical methods and performing sample analysis. Now, the International Council for Harmonisation (ICH) has released a new guideline that aims to standardize bioanalytical method validation (BMV) practices. [1] The final step 5 ICH M10 guideline, adopted on May 24, 2022, has been ratified by […]…Continue Reading
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Microsampling and Dried Blood Spot (DBS) Techniques in Bioanalytical Assays
Microsampling Overview Dried blood spots (DBS) and capillaries/capillary microsampling are the two most used microsampling techniques. In this article, we will give an overview of current microsampling techniques, the advantages, and challenges involved, and showcase how microsampling can generate high-quality bioanalytical data and accurate TK/PK profiling. Microsampling is a process through which low-volume samples (<100 […]…Continue Reading
Critical Reagents Usage in Bioanalytical Labs: Q+A with Dr. Santosh Shah
In this Q+A, Dr. Santosh Shah answers key questions about critical reagent use and management for ligand binding assays….Continue Reading
Flow Cytometry in Early Drug Discovery
In this article, we talk about the value of flow cytometry in early phases of drug discovery….Continue Reading
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