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 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FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH. FDA announced the availability of a draft guidance for industry, “M10 Bioanalytical Method ...
DUBLIN--(BUSINESS WIRE)--The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" conference has been added to ...
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 ...
Nonclinical dose formulation analysis methods are used to confirm test article concentration and homogeneity in formulations and determine formulation stability in support of regulated nonclinical ...
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 ...
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