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- W137017020 abstract "This chapter will focus on how to overcome biopharmaceutical and technical hurdles of a given compound during drug discovery and determine a go/no-go development path utilizing minimum resources, material and time. An early assessment of developability and associated risks during drug discovery can expedite the candidate selection process, enable developable candidates to move faster into clinic and weed out non-developable candidates sooner rather than later. A number of desirable physicochemical and biopharmaceutical properties can be incorporated into a compound during lead optimization stage. However, there are instances, such as discovery programs targeting unmet medical needs or highly hydrophobic target/enzymes, where early intervention of enabling formulation and delivery technologies might be required. Therefore, a number of developability assessment approaches, either alone or in combination, can be applied prior to candidate selection. Such approaches include in silico predictions, surrogate measurements mimicking biorelevant conditions, learnings from related compounds and rapid screening of multiple solid forms, formulation and delivery technologies. In the end, a cross-functional package of data from physicochemical, biopharmaceutical, ADME, PK/PD, and delivery technology should be available for interpretation to the discovery and pre-development teams so that a balanced portfolio is achieved before a candidate enters into full development. This chapter discusses how one takes the entirety of data from a program to assess the feasibility/likelihood of success and provides recommendation, defines risk and mitigation plan for a selected development candidate from IND-enabling studies to commercialization." @default.
- W137017020 created "2016-06-24" @default.
- W137017020 creator A5020834607 @default.
- W137017020 creator A5050602449 @default.
- W137017020 date "2014-09-27" @default.
- W137017020 modified "2023-10-01" @default.
- W137017020 title "Developability Assessment and Risk Management During Drug Discovery" @default.
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