Joint AAPS/USP Webinars on Drug Performance Testing

The USP Expert Panel New Advancements in Product Performance Testing performed a gap analysis on the need for and possible creation of tests and standards for measuring the performance of drug products. This webinar series will highlight challenges of specific product performance tests, such as injectables, mucosal, inhalation, nasal, continuous manufacturing, topical, transdermal, oral, and nanomaterials, and allow for further discussions and feedback from stakeholders.  Upon completion of the webinar series participants will understand the challenges as addressed in the stimuli articles and learn about existing tests, gaps and challenges involved in drug performance testing for various drug types

Challenges in In-Vitro Product Performance Testing of Mucosal Drug Products – Uncovering USP Perspectives

Description: Mucosal drug products represent a very heterogeneous group of dosage forms that are applied to various sites of the body. Performance testing of mucosal drug products presents the user with a multitude of challenges given various routes of administration. The webinar delivers a critical discussion on the methodological approaches, gaps, and challenges in mucosal product performance testing. In addition, it will highlight the USP General Chapter ⟨1004⟩ Mucosal Drug Products – Performance Tests, along with the related stimuli article, and emphasize the need for the development and standardization of meaningful In-Vitro product performance tests for mucosal drug products. Don’t miss this exciting webinar and register now!

Objectives: Upon completion of this specific webinar participants will understand:
• Currently available compendial test methods for mucosal drug products
• Current challenges due to the diversity of mucosal dosage forms
• Need for additional performance tests, methodological standardization.
• Factors to be considered while developing an in-vitro testing model for mucosal drug products.

Sandra Klein, Ph.D.

Sandra Klein, Ph.D. is a pharmacist by training and obtained her license to practice pharmacy and her PhD from the University of Frankfurt, Germany. She was a Postdoctoral Fellow at Eastman Chemical Company in Kingsport, TN, USA and has been a Professor of Pharmaceutical Technology at the University of Greifswald, Germany since 2010. Since starting her PhD, she has been working on the development of biorelevant in vitro methods to assess the bioavailability of orally administered drugs and meanwhile has more than 20 years of experience with biorelevant dissolution assays. Her current research focuses on the development of biopredictive in vitro models to estimate the in vivo performance of drugs for different patient populations, as well as the development of oral dosage forms for special patient populations, particularly pediatric patients. The latter activities span the spectrum from formulations for poorly soluble drugs through taste-masked formulations to controlled-release dosage forms. Other research interests include the development of predictive and accelerated in vitro release methods for lozenges, vaginal and rectal delivery systems, and long acting injectables. Sandra is a member of the American Association of Pharmaceutical Scientists (AAPS), the European Paediatric Formulation Initiative (EuPFI), the German Pharmaceutical Society (DPhG) and the International Association of Pharmaceutical Technology (APV). She is currently also the Vice President of the APV, an Expert Member of the USP Expert Panel on New Advancements in Product Performance Testing, an Expert Member of the conect4children (c4c) Formulations Expert Group, and Editor-in-Chief of Pharmazie, An International Journal of Pharmaceutical Sciences.