Investigation of Chiral Active Substances

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Status Last revised 1993 Previous titles/other references Clinical Investigation of Chiral Active Substances/ III/3501/91 Additional Notes This note for guidance considers active substances with one or more stereogenic centres which display chirality but not constitutional isomerism or cis/trans isomerism. It should be read in conjunction with Directive 65/65/EEC as amended and Directive 75/318/EEC as amended. Its contents are additional to the notes for guidance on quality, safety and efficacy which, where relevant, should be read in conjunction with this note.

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تاریخ انتشار 1998