Clinical Research Solutions
Understanding Analytical Method Validation
The core of my background was built upon analytical development science for biotechnology companies including Celera and Genentech. It became routine to develop analytical assays to test products...
Clinical Research Solutions
Are You Ready for AIQ? (Part II)
In the previous installment of this blog, we discussed the importance of establishing a Master Validation Plan, and how to plan and assess your validation approach. Today’s segment will complete the...
Clinical Research Solutions
Are You Ready for AIQ?
Do you find yourself in one of the following situations? + Your equipment has broken down due to frequent usage or wear and thus requires repair. You realize that once repaired, any equipment will...
Clinical Research Solutions
You Were Off By How Much?
Many active ingredient assay failures can be attributed to weighing and charging errors incurred during the compounding process. Even when the active ingredient is weighed and charged correctly,...
Clinical Research Solutions
Using Propagation of Error to Determine Validation Acceptance Criteria for In-Process Measurements
Many times in validation I am confronted with the problem of how to set acceptance criteria for critical process measurements. This is particularly true of in process measurements made during...
Clinical Research Solutions
Impact of Wavelength Accuracy and Precision on Spectrophotometric Measurements
Impact of Wavelength Accuracy and Precision on Spectrophotometric Measurements: A while back I was involved in a Quality Assurance project reviewing calibration specifications for analytical...
Clinical Research Solutions
Understanding Statistical Intervals: Part 3 - Tolerance Intervals
We saw in Part 1 of this series how a confidence interval can be calculated to define a range within which the true value of a statistical parameter such as a mean or standard deviation is likely to...