Method Development, Validation, Sample Analysis
INDEX OF TOPICS: 45 segments covered.
COURSE DURATION: 12 hours.
SUBSCRIPTION PERIOD: 12 Months.
Part I: Sample Preparation and Analysis
Lectures 1 – 6 step the student through the key aspects of LC/MS bioanalysis from the fundamentals of the technology to development of an analyte appropriate bioanalytical method. Particular emphasis is placed on using LC/MS techniques and technology that support compliance with regulatory requirements.
By considering analyte chemistry in development of the method, students will be able to better understand bioanalytical strategy and how it ultimately supports confidence in the final data.
Part II: Making sure you are Ready for an Inspection
Lectures 7-12 are developed for those new to quantitative LC/MS bioanalysis in support of regulated clinical and non-clinical studies. With a focus on small molecule drugs in biological fluids, the material covers the background on the regulations, the critical experiments of method validation and how to prepare for audits and inspections.
EStudents of the course will gain a firm understanding of the requirements of regulated bioanalysis and be able to put into context the practicalities of method development, method validation and study sample analysis.
Course to be added in the future..