Outsourcing Stability Programs

Stability studies are a critical part of the drug development process and are essential for regulatory approval. Stability studies are required at all phases of the drug development life cycle. They establish the groundwork for understanding if the drug candidate is viable. Will the dose range and the formulation prove to be sufficiently robust to support the candidate’s safety and efficacy? The information gained from these stability studies will help the pharmaceutical company determine and drive the drug development process. Decisions regarding the safe dosing range, excipients and active pharmaceutical ingredient (API) compatibility, formulation considerations, requirements essential for regulatory approval, expiration dating and quality control, are all supported by stability studies.