GMS5007 Regulation of Generic Medicines

 
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Generic medicines are becoming increasingly important as a means of providing access to affordable healthcare by helping to suppress rising healthcare costs. This course aims to equip students with skills to assess the therapeutic equivalence of a generic medicinal product relative to a comparator, specifically with respect to bioavailability (BA) and bioequivalence (BE).

In this course, students will learn how to design and conduct appropriate bioavailability and bioequivalence studies in accordance with established international guidance documents, and to analyse the data from such studies.

Learning Outcomes

  • Understand the important role of generic medicines in public health, and also the different regulatory requirements in managing these health products.
  • Gain basic skills for reviewing market approvals of generics, which are largely based on studies of bioavailability and bioequivalence. The technical aspects of these critical review processes will be taught in this module, and also
  • Explore trends in the assessment of other dosage forms beyond solid oral medicines.

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