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PubMed · 14962588

Polymorphism in generic drug product development.

Daniel A Snider·William Addicks·Walter Owens
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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.

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Biological AvailabilityCalorimetry, Differential ScanningDatabases, BibliographicDrug CompoundingDrug IndustryDrugs, GenericExcipientsHumansMetoprololMolecular ConformationParticle SizePhase TransitionSolubilitySolventsSpironolactoneTechnology, PharmaceuticalTerfenadineTherapeutic EquivalencyWettabilityJournal ArticleReview

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Daniel A Snider, William Addicks, Walter Owens. 2004-02-23. Polymorphism in generic drug product development.. https://doi.org/10.1016/j.addr.2003.10.010

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