Clinical Research Solutions
Assay Streamlining, Benefits and Drawbacks
As a biopharmaceutical company matures and new products are added to its portfolio, expansion of its facilities, systems and Quality Control is a natural outcome. The growth in the Quality Control...
Clinical Research Solutions
To Requalify or to Continuously Monitor, That is the Question
Your manufacturing equipment and processes have been established, qualified and validated; all you have to do now is rake in the profits right? Think again, the process of maintaining the validated...
Clinical Research Solutions
Understanding Statistical Intervals: Part 2 - Prediction Intervals
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...
Clinical Research Solutions
Understanding Statistical Intervals Part 1 - Confidence Intervals
Statistical intervals are staples of the quality and validation practitioner’s statistical tool box. Statistical intervals can manifest as plus-or-minus limits on test data, represent a margin of...