Journal
ADVANCED DRUG DELIVERY REVIEWS
Volume 56, Issue 3, Pages 391-395Publisher
ELSEVIER
DOI: 10.1016/j.addr.2003.10.010
Keywords
polymorphism; generic; DSC; dissolution; compressibility; formulation; bioequivalence
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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. (C) 2003 Published by Elsevier B.V.
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