Investigation of chiral active substances (human) - Scientific guideline

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This document intends to explain the requirements for studies of chiral active substances during the development of a medicinal product. It considers active substances with one or more stereogenic centres which display chirality but not constitutional isomerism or cis/trans isomerism.

Keywords: Chirality, stereogenic centre, isomerism, stereoisomers, enantiomer, diastereoisomers, racemat

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