The US Food and Drug Administration (FDA) on Monday finalized guidance revised in 2013 to help companies validate bioanalytical methods used in human clinical pharmacology, bioavailability (BA) and ...

The European Medicines Agency (EMA) on Thursday released for public consultation the International Council of Harmonisation’s (ICH) M10 guideline, which aims to help sponsors improve the quality and ...

Bioanalytical method development and validation are at the forefront of ensuring rigorous, reproducible and reliable data in both drug development and clinical diagnostics. The field encompasses the ...

Announcing a new article publication for BIO Integration journal. Ellagic acid (EA) is a natural polyphenolic compound recognized for bioactive and pharmacologic properties that is found abundantly in ...

In a recent editorial published in Current Pharmaceutical Analysis (Volume 18, Issue 6, 2022), researchers Dr. Behrouz Seyfinejad and Dr. Abolghasem Jouyban highlight the importance of method ...

AI and ML enhance bioanalysis by improving data evaluation, report writing, and quality control, with constraints to prevent inaccuracies. Advanced instrumentation, such as improved flow cytometry and ...

As sponsors require higher throughput, managers are forced to do more with the same or fewer resources, which causes a strain in scientific depth. This pressure increases as the complexities of ...

At virtually every stage of the processes required to bring a new drug to market—from early discovery through clinical trials—biopharma scientists would like more information. More insight into the ...