How incoming guidelines on chiral drugs could impact on the international scenery of drug development.IUPAC.
In this review incoming guidelines on chiral drugs are examined for their impact on drug development. Problems related to synthesis, enantiomeric resolution, analytics, pharmacokinetics, preclinical and clinical studies are discussed throughout the paper. Problems related to the validation of an enantioselective assay in pharmacokinetics are certainly the most difficult, mainly for chiral drugs active at low or very low plasma concentrations. The compliance with incoming guidelines on chirality will require new approaches and new technologies and will produce an increased cost of the drug development.
Marzo
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Drug Metabolism and Pharmacokinetic Department Sigma-Tau S.p.A., Pomezia-Roma.
D004345:Drug Industry; D017408:Guidelines as Topic; D010599:Pharmacokinetics; D010600:Pharmacology; D013237:Stereoisomerism