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An industrial approach towards solid dosage development for first-in-human studies: Application of predictive science
Dhaval R Kalaria1, Keith Parker1, Gavin K Reynolds2
1Early Product Development, Pharmaceutical Sciences, R&D, AstraZeneca, Macclesfield, UK.
Abstract:
Tablet development is challenging during early clinical phases of drug discovery because of dose uncertainty, limited active pharmaceutical ingredient availability, and short lead times. Here, we introduce a new framework to expedite product development using a suite of in-house and commercially available predictive tools developed through the integration of computer modelling and material-sparing characterisation methods. The strategy underpins the use of dry granulation for formulation development with guidance on scale-up and manufacturability to achieve 'First Time Right'. We present an analytical strategy based on predictive science with a focus on stability, and shelf-life related attributes to assure product quality. Thus, we provide a holistic approach towards robust, scientific product development through integrated project knowledge and risk-based approaches, delivering significant savings in both material and resources.
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