Investigation of chiral active substances

Table of contents

This guideline applies to human and veterinary medicines.

Keywords Chirality, stereogenic centre, isomerism, stereoisomers, enantiomer, diastereoisomers, racemat
Description 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.

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