In 2019 USP created an Expert Panel (New Advancements in Product Performance Testing) to do a gap analysis on the need for and possible creation of tests/standards for measuring the performance of drug products. The results of Working Groups within the Expert Panel have been presented in a series of articles in Pharmacopeal Forum and Dissolution Technology. The purpose of this webinar is to present to stake holders and interested members of the pharmacy community, the findings of the Working Group on orally administered products and allow for questions and suggestion from participants for improvement/modifications for the Working Group’s findings.

Learning Objectives:
• Understand the role of stimuli article as opposed to Official or Informational Chapters in the United States Pharmacopeia (USP).
• Describe the process used by the USP Expert Panel to identify existing tests, gaps and challenges involved in drug performance testing.

• Evaluate the findings of the Working Group for oral products as presented in the stimuli article.
• Question and provide input to the findings of the Working Group for Oral Drug Products

Nikoletta Fotaki, MSc, Ph.D., FAAPS
Prof. Nikoletta Fotaki is a Professor of Biopharmaceutics at the University of Bath, UK. She graduated in Pharmacy from the National and Kapodistrian University of Athens in Greece and she holds an MSc in Toxicology and a PhD in Biopharmaceutics-Pharmacokinetics. Her expertise and research are focused on PBPK modeling/ PBBM, in vitro and in silico tools for predicting absorption in normal populations and in special populations, dissolution methods, IVIVCs and biowaivers. Her scholastic work includes more than 90 peer reviewed publications, one book, 10 book chapters, 87 published conference contributions and 2 patents. She is an AAPS Fellow and a member of the AAPS Board of Directors with leading roles in the OBAM and IVRDT AAPS Communities. She is also the chair of the Biopharmaceutics Group of APS and she is a member of a USP expert panel and of several scientific societies and has been an invited speaker at several conferences.