API development strategies for oral dosage forms

Published: 6-Oct-2015

The costly and lengthy nature of drug development has long been accepted as a given. But can industry do something about it? Catalent argues that it could, if the current linearity of the development process were replaced with a multidisciplinary approach at the outset

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There has been, and by its nature always will be, a linear nature to drug discovery – where there are defined stages of progression, such as from discovery, through pre-clinical phases, and into clinical development. As such, the time taken to launch a new drug is lengthy, and consequently, costly.

Figures vary greatly as to the true cost of a drug’s development; however, a recent report1 gave an average cost of US$1.4bn, with a true cost, when incorporating time costs or expected returns that investors forego while a drug is in development, of $2.6bn.

One way to reduce the time spent on development is to carry out certain stages in parallel. However, this involves planning from the outset, and for cross-functional teams across several areas of research and development, common goals have to be established to gain efficiency that translates into both time and monetary savings.

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