Investigation of chiral active substances (human) - Scientific guideline
HumanScientific guidelines
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