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 ...
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 ...
A new draft guidance document released by the US Food and Drug Administration (FDA) aims to assist sponsors of investigational new drug applications (INDs), biologic license applications (BLAs) and ...
FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH. FDA announced the availability of a draft guidance for industry, “M10 Bioanalytical Method ...
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 ...
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 ...
Results that may be inaccessible to you are currently showing.
Hide inaccessible results