Robert T. Magari, Ph.D.


Assessing Shelf Life Using Real-Time and Accelerated Stability Tests

Biopharmaceutical products in storage change as they age, but they are considered to be stable as long as their characteristics remain within the manufacturer's specifications. The number of days that the product remains stable at the recommended storage conditions is referred to as the shelf life.

Statistics for Laboratory Method Comparison Studies

by Robert T. Magari, Beckman Coulter Corporation In laboratory testing, you may want to use a new analytical method for measuring a chemical substance. To do so, you must be able to prove that the new method gives the same results as the previous one. Not all statistical methods for making laboratory comparisons are equally valid.