STEREOISOMERIC DRUGS - FDAS POLICY STATEMENT AND THE IMPACT ON DRUG DEVELOPMENT

Authors
TOMASZEWSKI J RUMORE MM
Citation
J. Tomaszewski et Mm. Rumore, STEREOISOMERIC DRUGS - FDAS POLICY STATEMENT AND THE IMPACT ON DRUG DEVELOPMENT, Drug development and industrial pharmacy, 20(2), 1994, pp. 119-139
Citations number
31
Categorie Soggetti
Pharmacology & Pharmacy
Journal title
Drug development and industrial pharmacy → ACNP
ISSN journal
03639045
Volume
20
Issue
2
Year of publication
1994
Pages
119 - 139
Database
ISI
SICI code
0363-9045(1994)20:2<119:SD-FPS>2.0.ZU;2-3
Abstract
On May 1, 1992 FDA issued its long awaited policy statement concerning the development of stereoisomeric drugs. These drugs are also known a s ''chiral drugs.'' This paper will focus on the historical perspectiv e of the stereoisomer issue, review of FDA's policy and a discussion o f the potential impact of this policy on drug development including th e impact on marketing exclusivity.