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Lecture 12: Regulatory Aspects for Poorly Soluble Drugs

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Upon completion of this lecture of the eCourse, the participant should be able to:
  • Discuss how to develop a suitable dissolution method for poorly soluble drug products
  • Explain regulatory expectation with respect to control of polymorphism & particle size distribution for poorly soluble drugs
  • Demonstrate how to establish appropriate specifications for polymorphism and particle size specification based on commonly seen deficiencies in NDA/ANDA submissions.