Browsing: Regulated bioanalysis

regulation guidelines

Bioanalytical methods must enable the delivery of data that meet sound, scientifically justified, fit-for-purpose criteria. This perspective piece highlights three tiers of method validation – regulatory, scientific and research validations. The criteria for selecting the appropriate application of each of these PK method validation workflows are discussed.

Guidelines/Regulatory feature x1280

This 2016 White Paper encompasses recommendations emerging from the extensive discussions held during this years 10th Workshop on Recent Issues in Bioanalysis (10th WRIB) which took place in Orlando, Florida earlier this year. The report is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. This part (Part 1) discusses the recommendations for small molecules, peptides and small molecule biomarkers by LC–MS

1 2 3 22