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
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