All about bioanalysis
We explore the techniques, methods and advances regarding bioanalysis of small molecules, biologics and nucleic acids to improve patient health
Fit-to-purpose bioanalytical methods: scientific validation
Over the past 25 years the criteria required for bioanalytical methods has evolved significantly. The harmonization of bioanalytical methods requirements started in 1990 during the AAPS and FDA Crystal City Meetings. In 2000 the Crystal City II Meeting laid the foundations of the 2001 FDA Guidance on Bioanalytical Method Validation. In 2011 EMA launched his (...) Read more
