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The Biopharmaceutical Classification System (BCS) categorizes drug substances based on their solubility and permeability to predict their absorption and bioavailability.

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Companies involved in biopharmaceutical research and development, including pharmaceutical manufacturers and researchers, are required to file under this classification system.

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To fill out the Biopharmaceutical Classification System form, one must assess the solubility and permeability of the drug substance, and categorize it accordingly into one of the four BCS classes.

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The purpose of the Biopharmaceutical Classification System is to provide a framework for predicting the absorption of drug substances, guiding formulation and development decisions.

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The information that must be reported includes the drug's solubility, permeability, and related pharmacokinetic data.