Polymorphism in generic drug product development

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Abstract

The affect of polymorphism in the development of generic drug products is discussed. The desired polymorphic form is used based upon the ability to manufacture a bioequivalent product. The critical issues are control of the polymorphic form of the drug substance and the dissolution behavior of the drug product. © 2003 Published by Elsevier B.V.

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Snider, D. A., Addicks, W., & Owens, W. (2004). Polymorphism in generic drug product development. Advanced Drug Delivery Reviews, 56(3), 391–395. https://doi.org/10.1016/j.addr.2003.10.010

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