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 ...

FDA updates guidance to reflect advances in technology. FDA has updated a 2001 guidance on bioanalytical method validation because of advances in bioanalytical technology and science. Guidance for ...

Bioanalytical studies are a significant part of biologic drug development that may require partnering with bioanalysis experts. Bioanalytical studies are an important aspect in biologic drug ...

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 ...

This vendor-neutral ISR guide is designed to educate pharmaceutical scientists on using the technique to effectively assess the quality of bioanalytical methods. It contains up-to-date information on ...

Bioassay variability can pose significant challenges due to laboratory conditions, instrumentation, analytical software, cell ...

The data generated using analytical methods is essential for many of the critical decisions made in the pharmaceutical industry. To be confident in the reliability of this data it is crucial that the ...