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- W2005231010 abstract "An understanding of solid-state chemistry, including polymorphism, can reduce the time to filing an investigative new drug (IND) application. Obtaining a stable formulation for IND studies is crucial and must be the focus of much of the early solid-state chemistry research. Simple formulations such as a chemical substance in capsule (CIC) – the chemical substance can be crystalline or amorphpous – are preferable for the IND trial and the solubility/dissolution rate has an important role in manufacturing IND clinical supplies. Two fast-to-IND flowcharts are presented here for exploratory IND and conventional IND. The utilization of quality by design and process analytical chemistry (PAT) concepts at an early stage will lay the foundation for the accelerated development of the medicines that are successful in the IND trials." @default.
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- W2005231010 date "2007-03-01" @default.
- W2005231010 modified "2023-09-25" @default.
- W2005231010 title "Designing a molecular delivery system within a preclinical timeframe" @default.
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- W2005231010 doi "https://doi.org/10.1016/j.drudis.2007.01.006" @default.
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