Outsourcing stability testing
Third party providers offer both the infrastructure and breadth of experience to help clients arrange testing programmes that are relevant, cost-effective and as streamlined as possible.
Stability testing is one of the most crucial steps in the development of new drug products and critical to ensuring patient safety. Essentially the purpose of stability testing is to determine whether any physical, chemical or microbiological changes have an effect on the efficacy and integrity of a product and ultimately ensure both safety and successful treatment.
Developing an appropriate stability testing program to produce clear quality data is essential to getting a drug to market. As the complexity of the molecules entering the drug pipeline increases so to does the demand for specific expertise surrounding stability testing and meeting regulatory requirements. As a result, more and more companies are looking to third parties, like Recipharm, to carry out high quality, complex stability studies to accelerate their drugs to market.
Ramesh Jagadeesan Ph.D, Senior Director – Analytical Development at Recipharm
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