Stability Testing for Small-Molecule Clinical Trial Materials

Abstract

The essential purpose of these stability studies, adds Geoff Carr, director of analytical development for Patheon Pharma Services by Thermo Fisher Scientific, is to ensure that CTMs will remain satisfactory over the period that they are intended to be administered to subjects enrolled in the clinical study, which is often dependent on the clinical trial phase. The key challenge is the fact that as candidates progress through the development cycle, typically changes are made to the formulation, manufacturing process, analytical methodology, container closure system (CCS), or other aspects. What is important, adds Carr, is the strategy for method development/validation. Because CTMs are considered GMP even at Phase I, at least some validation of analytical procedures is required. Other factors to consider include stability testing of placebos and comparator products, climate zones the product may be exposed to, using batches of drug product manufactured to established procedures, and prioritizing patient safety while collecting reliable clinical data.