Strategies for Setting Patient-centric Quality Standards

The traditional method of creating specifications and control strategies based primarily on material, and thus its associated attributes, used in clinical studies can create limitations for the supply of medicinal products and hamper continuous improvement efforts. Other sources of data should be considered that allow for an increased understanding of what is relevant to the patient – the patient centric approach. This data can be product or class specific and come from prior knowledge, in vitro and in vivo studies, molecular modeling etc. This provides a more relevant and holistic data set on which to base the tests and limits that make up a patient centric control strategy