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It is still unclear whether changes in microbiota directly cause changes in bile acids, whether bile acids have an effect on the microbiota, or whether both are outcomes of LT therapy

DOI: 10.1002/fsn3.1818 34

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The full description of each category should be read on the FDAs website, but in short, materials listed in Category 1 may be used as bulk drug substances provided that all other relevant legal and regulatory conditions are met