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Why Pre-formulation Studies are Crucial to Successful Drug Development

机译：为什么预制剂研究对于成功的药物开发至关重要

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It is vital to understand the behaviour of a new active pharmaceutical ingredient (API) under various stress conditions to provide a solid foundation for development of a robust dosage form which can survive processing and a prolonged shelf live. The result of a poor, or no, pre-formulation study could be increased time and cost of drug development, an unstable product, or worse. Efforts taken on comprehensive pre-formulation studies are more than repaid via cost and time savings. Newly discovered proteins identified through genomics, proteomics, or traditional medical research have historically been utilised in drug development with minimal knowledge about their mechanisms of action, structural characteristics and biochemical properties. Proteins are inherently unstable, which has potential to alter its desired form, which could significantly compromise not only the drug's efficacy, but patients' safety. This is why pre-formulation is such an essential part of the drug development process. It is the group of studies undertaken in early biopharmaceutical development, prior to formulation development, focused on discovering the physicochemical properties of a new drug molecule which could affect its performance and consequent dosage form. It provides a scientific sketch of the drug in development.
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