Strategies for Biowaiver Application for Generic Nasal Sprays

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  • When: October 27, 2016
  • Time: 2PM (ET, US & Canada)
  • Presenters: David Exline, President, Gateway Analytical, and Julie D. Suman, Ph.D.,
    President, Next Breath, LLC

Replay Webinar


The active pharmaceutical ingredient (API) size distribution within the final formulation of a drug product is critical as it relates to bioavailability, rates of absorption, and stability of that drug product. Gaining an understanding of the API particle size distribution (PSD) is becoming of greater importance to regulatory agencies, particularly as they relate to the Critical Path Opportunity and biowaiver applications. In fact, a successful ANDA application for mometasone furoate nasal spray utilized Raman spectroscopy as an in vitro study technology in lieu of repeating a clinical endpoint study.

In this webinar, Gateway Analytical will highlight techniques using Raman spectroscopy for abbreviated new drug applications (ANDA) with FDA. Next Breath will present an overview of in vitro bioequivalence requirements and approaches incorporating this new technique.

Analysis using automated Raman technology that combines optical microscopy and Raman spectroscopy will be described. Interpretation of single and agglomerated particles sizes will be presented. In addition, the pros and cons of various instrument approaches will be highlighted. The webinar will conclude with an overview of Gateway’s and Next Breath’s combined strategy for establishing in vitro bioequivalence for regulatory submissions.

Presenter Bios

David Exline

David Exline

David Exline, President, Gateway Analytical

David Exline has more than 20 years of experience in the areas of managing and administering analytical laboratories and consulting services. As the president of Gateway Analytical, he oversees the company’s day-to-day operations, business growth and service areas.

David has specific expertise in applying chemical imaging methods such as Raman, UV-Vis and NIR techniques to solve the most difficult pharmaceutical and material science problems for Gateway customers. David is adept in numerous pharmaceutical-related services and testing methods including: materials characterization, particulate contamination analysis, particle sizing and high-resolution microscopy.


Julie Suman RDD EU 2011

Julie D. Suman, Ph.D.

Julie D. Suman, Ph.D. , President, Next Breath, LLC

Dr. Julie D. Suman is co-founder and President of Next Breath, LLC, a contract research organization dedicated to the development and analytical testing of nasal and inhalation delivery systems. Dr. Suman directs the research division that supports product development and regulatory submissions for North American and International Clients in the pharmaceutical, biotechnology and medical device markets. Dr. Suman holds a B.S. in Pharmacy from Duquesne University (1996) and a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore (2002). She is a co-editor for Respiratory Drug Delivery Proceedings, an international symposium, and an adjunct assistant professor at the University of Maryland, School of Pharmacy in Baltimore, Maryland. She is also an Affiliate Assistant Professor in the Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University. Dr. Suman is the Past-Chair of the AAPS Inhalation Technology Focus Group. She is also a licensed Maryland pharmacist. Dr. Suman has published her research in peer-reviewed journals and has been presented during podium sessions at international meetings, the FDA Visiting Professor Lecture Series and has been an invited speaker at ANVISA in Brazil. Dr. Suman’s doctoral research, which focused on the relationship between in vitro tests for nasal sprays and in vivo deposition, has been recognized for excellence by a research award presented at the International Society for Aerosols in Medicine, 2001. In 2008, Dr. Suman received an award from the Greater Baltimore Committee for Entrepreneurial Spirit.

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