Desai, N; Edwards, AJ; Ernest, TB; Tuleu, C; Orlu, M; (2020) 'Big Data' informed drug development: a case for acceptability. Drug Discovery Today 10.1016/j.drudis.2020.12.011. (In press).

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Abstract

Data, which help inform various stages of drug product development, are increasingly being collected using newer, more novel platforms, such as mobile applications, and analysed computationally as much larger 'Big Data' data sets, revealing patterns relating to human behaviour and interactions. Medicine acceptability gauges the ability and willingness of patients to take their dosage forms. It has become a crucial human component of drug product design. Vouching for the age appropriateness of medicinal products, acceptability related data are now expected by regulatory bodies. Shifting from traditional paper-based to electronic data-gathering platforms will allow the pharmaceutical industry to collect real-world, real-time, clinically relevant data, capable of informing current and future drug product development, reducing time and cost, and setting foundations for patient-centric drug product design.

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