• Publication Date: 02/01/2009
  • Author(s):
    Dalby, Richard Doughty, Diane V. Hsu, Wenchi Jin, Feiyan Kundoor, Vipra
  • Organization(s):
    University of Maryland, Baltimore
  • Article Type: Technical Articles
  • Subjects: Nasal Delivery, Testing, Validation, and Regulatory Compliance
Interest in new test methods for bioequivalence of inhaled and nasal drug products is growing - are there alternative ways forward?

A reliance on in vitro testing could aid in the timely approval of generics and could reduce time and expense for the development of novel products. Cost effective and efficient methods to establish bioequivalence would benefit the development of both brand-name and generic pharmaceuticals, saving both companies and consumers significant amounts of money. Much of the current interest in bioequivalence stems from a desire to introduce improved methods of testing to achieve these objectives, and several new, potentially more meaningful, in vitro methods show promise in that area.

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