Abstract
This chapter provides an overview of the concepts of quality and risk in early development. It utilizes the FDA quality by design wheel and emphasizes the concept of learning before doing. This chapter also emphasizes stability and factors that lead to instability. Finally, this chapter addresses moisture and moisture uptake.
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Byrn, S.R. (2015). Predictive Approaches to Establishing, Understanding, and Communicating Risk with Emphasis on Early Development. In: Templeton, A., Byrn, S., Haskell, R., Prisinzano, T. (eds) Discovering and Developing Molecules with Optimal Drug-Like Properties. AAPS Advances in the Pharmaceutical Sciences Series, vol 15. Springer, New York, NY. https://doi.org/10.1007/978-1-4939-1399-2_6
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