Development of Stereoisomeric (Chiral) Drugs: A Brief Review of Scientific and Regulatory Considerations

Stereoisomers are molecules that are identical to one another in terms of atomic constitution and sequence of covalent bonds, but which differ in the three dimensional arrangement of atoms. There is a growing belief that enantioselectivity in the pharmacodynamic and pharmacokinetic properties of a d...

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Bibliographic Details
Published in:Drug information journal 1997, Vol.31 (3), p.639-646
Main Authors: Daniels, Jonathan M., Nestmann, Earle R., Kerr, Alex
Format: Article
Language:English
Subjects:
Biological and medical sciences
General pharmacology
Medical sciences
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Physicochemical properties. Structure-activity relationships
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Summary:Stereoisomers are molecules that are identical to one another in terms of atomic constitution and sequence of covalent bonds, but which differ in the three dimensional arrangement of atoms. There is a growing belief that enantioselectivity in the pharmacodynamic and pharmacokinetic properties of a drug is not a rare phenomenon, but occurs rather frequently. Because of differences in pharmacological activity between enantiomers, racemic mixtures can, in theory, be seen as combination products. Recognition of potential differences of pharmaceutical enantiomers has led to increasing attention by regulatory agencies to developments with such compounds. This paper will briefly review the scientific and regulatory guidance provided for the development and approval of chiral drugs in Canada, and relate this to the requirements currently in place in the United States and Europe.
ISSN:2168-4790
0092-8615
2168-4804
2164-9200
DOI:10.1177/009286159703100303