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.

中文翻译：

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用于首次人体研究的固体剂量开发的工业方法：预测科学和精益原则的应用。

由于剂量不确定、活性药物成分的可用性有限和交货时间短，片剂开发在药物发现的早期临床阶段具有挑战性。在这里，我们引入了一个新框架，以使用通过集成计算机建模和材料备用表征方法开发的一套内部和商用预测工具来加快产品开发。该策略支持使用干法制粒进行制剂开发，并指导扩大规模和可制造性，以实现“首次正确”。我们提出了一种基于预测科学的分析策略，重点是稳定性和与保质期相关的属性，以确保产品质量。因此，我们提供了一种实现稳健、