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Literature DB >> 8485501

Development and registration of chiral drugs.

D T Witte¹, K Ensing, J P Franke, R A De Zeeuw.

Abstract

In this review we describe the impact of chirality on drug development and registration in the United States, Japan and the European Community. Enantiomers may have differences in their pharmacological profiles, and, therefore, chiral drugs ask for special analytical and pharmacological attention during their development. However, the registration authorities have no clear policy towards the registration of chiral drugs. The absence of a clear policy regarding chirality causes a great deal of confusion and frustration at various levels and is not in the interest of industries developing newer and more beneficial drugs.

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Year: 1993 PMID： 8485501 DOI： 10.1007/bf02116164

Source DB: PubMed Journal: Pharm World Sci ISSN： 0928-1231

20 in total

1. Atropine and the hyoscyamines-a study of the action of optical isomers.

Authors: A R Cushny
Journal: J Physiol Date: 1903-11-02 Impact factor: 5.182

Review 2. Chiral drugs: an industrial analytical perspective.

Authors: T J Wozniak; R J Bopp; E C Jensen
Journal: J Pharm Biomed Anal Date: 1991 Impact factor: 3.935

3. Some chemical and stereochemical aspects of diethylpropion metabolism in man.

Authors: B Testa
Journal: Acta Pharm Suec Date: 1973-12

Review 4. The metabolic chiral inversion of 2-arylpropionic acids--a novel route with pharmacological consequences.

Authors: A J Hutt; J Caldwell
Journal: J Pharm Pharmacol Date: 1983-11 Impact factor: 3.765

5. Utilization of an enantiomer as a solution to a pharmaceutical problem: application to solubilization of 1,2-di(4-piperazine-2,6-dione)propane.

Authors: A J Repta; M J Baltezor; P C Bansal
Journal: J Pharm Sci Date: 1976-02 Impact factor: 3.534

6. Racemization kinetics of enantiomeric oxazepams and stereoselective hydrolysis of enantiomeric oxazepam 3-acetates in rat liver microsomes and brain homogenate.

Authors: S K Yang; X L Lu
Journal: J Pharm Sci Date: 1989-10 Impact factor: 3.534

2. Determination of enantiomeric compositions of analytes using novel fluorescent chiral molecular micelles and steady state fluorescence measurements.

Authors: Alicia A Williams; Sayo O Fakayode; Onur Alptürk; Christina M Jones; Mark Lowry; Robert M Strongin; Isiah M Warner
Journal: J Fluoresc Date: 2007-11-06 Impact factor: 2.217

2 in total

Development and registration of chiral drugs.

1. Atropine and the hyoscyamines-a study of the action of optical isomers.

Review 2. Chiral drugs: an industrial analytical perspective.

3. Some chemical and stereochemical aspects of diethylpropion metabolism in man.

Review 4. The metabolic chiral inversion of 2-arylpropionic acids--a novel route with pharmacological consequences.

5. Utilization of an enantiomer as a solution to a pharmaceutical problem: application to solubilization of 1,2-di(4-piperazine-2,6-dione)propane.

6. Racemization kinetics of enantiomeric oxazepams and stereoselective hydrolysis of enantiomeric oxazepam 3-acetates in rat liver microsomes and brain homogenate.

7. Enhancement of uricosuric properties of indacrinone by manipulation of the enantiomer ratio.

8. Flecainide enantiomers: disposition in human subjects and electrophysiologic actions in vitro.

9. Metabolic stereoisomeric inversion of ibuprofen in mammals.

10. Pharmacokinetics of ibuprofen enantiomers in dogs.

Review 1. An overview of chiral separations of pharmaceutically active substances by HPLC (2018-2020).

2. Determination of enantiomeric compositions of analytes using novel fluorescent chiral molecular micelles and steady state fluorescence measurements.