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Stereochemistry and bioequivalence.

F Jamali1

  • 1Faculty of Pharmacy, University of Alberta, Edmonton, Canada.

Journal of Clinical Pharmacology
|October 1, 1992
PubMed
Summary

Many chiral drugs are sold as racemates, but enantiomers can have different effects. Stereospecific assays are crucial for accurate bioequivalence assessment, especially for generic drugs.

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Area of Science:

  • Pharmacology
  • Drug Development
  • Analytical Chemistry

Background:

  • Many essential drugs are chiral and marketed as racemic mixtures (equal parts of two enantiomers).
  • Enantiomers of the same drug can exhibit distinct pharmacodynamic and pharmacokinetic profiles.
  • Current bioequivalence studies often use nonstereospecific assays, potentially misrepresenting therapeutic equivalence.

Purpose of the Study:

  • To highlight the limitations of nonstereospecific bioequivalence assays for chiral drugs.
  • To emphasize the growing importance of stereospecific assays in drug assessment.
  • To inform regulatory considerations regarding stereochemistry in generic drug substitution.

Main Methods:

  • Review of existing literature on chiral drugs, racemates, and bioequivalence studies.
  • Analysis of the impact of stereoselectivity on drug disposition kinetics.
  • Examination of the emergence and availability of stereospecific analytical methods.

Main Results:

  • Nonstereospecific assays may inadequately assess therapeutic equality, particularly for drugs with complex pharmacokinetics or high stereoselectivity.
  • Stereospecific bioequivalence studies are increasingly reported in scientific literature.
  • Advancements in analytical techniques have made stereospecific assays more accessible.

Conclusions:

  • Stereochemistry is a critical factor in drug bioequivalence and therapeutic outcomes.
  • Regulatory agencies are beginning to incorporate stereochemistry into bioequivalence assessments for generic drugs.
  • The use of stereospecific assays is essential for ensuring the safety and efficacy of chiral generic medications.

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