FEATURED
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
MOST RECENT
A Complete Overview of DART (Developmental and Reproductive Toxicology) Studies
Developmental and Reproductive Toxicology studies assess critical information about drug exposure effects before and during mating, and evaluate maternal and fetal changes during gestation, identifying any alterations in the development of the progeny following birth. In essence, these studies elucidate the toxicity effects of the compound in question. …Continue Reading
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
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RESULTS
Implementing ICH M10: Finally, a Harmonized Bioanalytical Method Validation Guidance
– A Complete Overview of DART (Developmental and Reproductive Toxicology) Studies
– Microsampling and Dried Blood Spot (DBS) Techniques in Bioanalytical Assays
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