Stereoisomeric Drugs: FDA'S Policy Statement and the Impact on Drug Development
- 1 January 1994
- journal article
- research article
- Published by Taylor & Francis in Drug Development and Industrial Pharmacy
- Vol. 20 (2), 119-139
- https://doi.org/10.3109/03639049409039080
Abstract
On May 1, 1992 FDA issued its long awaited policy statement concerning the development of stereoisomeric drugs. These drugs are also known as “chiral drugs.” This paper will focus on the historical perspective of the stereoisomer issue, review of FDA's policy and a discussion of the potential impact of this policy on drug development including the impact on marketing exclusivity.Keywords
This publication has 19 references indexed in Scilit:
- Beyond Nature's Chiral Pool: Enantioselective Catalysis in IndustryScience, 1993
- From Controversy to Resolution: Bioequivalence of Racemic Drugs—AbstractsThe Journal of Clinical Pharmacology, 1992
- The Importance of Stereochemistry in Drug Action and DispositionThe Journal of Clinical Pharmacology, 1992
- From Controversy to Resolution: Bioequivalency of Racemic Drugs—A Symposium on the Dynamics, Kinetics, Bioequivalency, and Analytical Aspects of StereochemistryThe Journal of Clinical Pharmacology, 1992
- Bioequivalence of Racemic DrugsThe Journal of Clinical Pharmacology, 1992
- Racemic (R,S)-propranolol versus half-dosed optically pure (S)-propranolol in humans at steady state: Hemodynamic effects, plasma concentrations, and influence on thyroid hormone levelsClinical Pharmacology & Therapeutics, 1992
- Chiral drugs: An industrial analytical perspectiveJournal of Pharmaceutical and Biomedical Analysis, 1991
- High-performance liquid chromatographic separation of the enantiomers of hydroxychloroquine and its major metabolites in biological fluids using an α1-acid glycoprotein stationary phaseJournal of Chromatography B: Biomedical Sciences and Applications, 1991
- Clinical pharmacology through the looking glass: reflections on the racemate vs enantiomer debate.British Journal of Clinical Pharmacology, 1991
- The FDA perspective on the development of stereoisomersChirality, 1989