AAPS Workshop on Inhalation Product Biopharmaceutical Classification

March 16, 2015

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The purpose of the AAPS Workshop is to determine if an inhalation biopharmaceutical product classification system (iBPCS) can be developed for both small molecule and biologic inhaled drug products based on the dose administered and fundamental physicochemical properties of physiological importance.

It is designed for senior level pharmaceutical scientists and formulation specialists, clinical pharmacologists and pulmonologists, aerosol engineers and analysts, and toxicologists working in the inhalation field.

The workshop will also:

  • Explore and identify the parameters required to establish an in vivo/in vitro correlation for inhaled products and their practical relevance
  • Provide a collaborative, cross-disciplinary forum for scientific discussion

Attendees will participate in one of three pre-selected breakout sessions to analyze and refine dose number, absorption number, and dissolution number and assess the biorelevance of these parameters for inhalation products. The key learnings from this workshop will be published as white paper.

Jeffrey Breit, PhD. Director at Bend Research, a division of Capsugel Dosage Form Solutions, is co-chair and program committee member for this event. 

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