Quality by Design: A Holistic Approach to Drug Development
As the biopharmaceutical industry continues to evolve, the Quality by Design (QbD) holistic and proactive approach to drug development and manufacturing is transforming key processes. In response to increased interest from global regulatory agencies, QbD seeks to further reduce the risk associated with drug development and bring much-needed therapies to market quicker.
Sponsors who implement QbD early can save money through increased product/process knowledge, less re-work, less product deviation, less product out-of-specification, fewer rejects and improved quality.
Authors:
Anil Kane, PhD, MBA, Executive Director, Global Head of Formulation Development, Patheon, by Thermo Fisher Scientific
Kaspar van den Dries, PhD, Senior Director and Principle Scientist Solid Dose Development, Patheon, by Thermo Fisher Scientific
Douglas Rufino, Vice President Global Corporate Quality, Pharmaceutical Development Services, Patheon, by Thermo Fisher Scientific
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