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Inhalation is the only technical publication devoted exclusively to readers involved in development and production of pulmonary or nasal delivered pharmaceuticals.

Inhaler Testing Methods for Orally Inhaled Products (OIPs):
How they are adjusting to support clinician needs towards
the improvement of
in vitro/in vivo relationships (IVIVRs)

Tuesday, August 5, 2014

Time:  12:00 PM (Noon) – 2:00 PM EDT

Presenter:  Dr. Jolyon Mitchell, Affiliate Professor, Daniel K. Inouye College of Pharmacy, University of Hawaii

Guest Moderator:  Dr. Terrence Tougas, Highly Distinguished Research Fellow, Analytical Development, Boehringer Ingelheim, Inc.

Moderator:  Vicki Schuman, Editor of Inhalation

Webinar Cost:  $99.00 USD

Registration fee is non-refundable after the live event.

Webinar Details:  Existing pharmacopeial methods for the in vitro testing of orally inhaled products (OIPs) are simplified representations of clinical reality, primarily because the goal is to provide robust metrics that can be used to assess product quality. Imaging-based techniques that quantify particle deposition in terms of location in the human respiratory tract may be helpful to link in vitro to in vivo data as surrogates for clinical responses. However, attempts to correlate laboratory-determined measures, such as fine particle fraction < 5 µm aerodynamic diameter, using pharmacopeial methods with clinical response factors have been notoriously difficult to achieve. A reappraisal of the purposes for laboratory-based testing of OIPs is therefore required if this problem is to be resolved satisfactorily. This webinar provides guidance on approaches that may be helpful to develop more clinically-appropriate methods to assess OIP performance in the laboratory, with the ultimate objective of developing robust in vitro/in vivo relationships (IVIVRs) for the major inhaled drug classes.

Presenter Information:  Jolyon Mitchell, Ph.D., F.R.S.C. (UK), C.Chem. C.Sci., is a consultant specializing in the laboratory evaluation of orally inhaled products (OIPs). He was formerly Scientific Director of Trudell Medical International. He serves as a Scientific Adviser to the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) and has an active role in the European Pharmaceutical Aerosol Group (EPAG). He played a major part in the development of two international standards (ISO 20072:2009 and ISO 27427:2010) covering OIPs, as well as a Canadian Standard for Spacers and Holding Chambers (CAN/CSA Z264.1-02:2002). In addition, he was appointed to the Expert Committee: General Chapters – Dosage Forms of the United States Pharmacopeial Convention for the 2010-2015 term, where he co-chairs the Aerosols sub-committee. He is an adjunct professor at the University of Western Ontario and an affiliate professor at the Daniel K. Inouye College of Pharmacy of the University of Hawaii at Hilo. He is also a member of the Editorial Advisory Boards of the Journal of Aerosol Medicine and Inhalation. He has published more than 350 articles in the open literature, including approximately 120 in peer-reviewed journals and 10 invited review articles. He has also contributed to five books on aerosol science.

Guest Moderator Information:  Terrence Tougas, Ph.D., is a Highly Distinguished Research Fellow in Analytical Development at Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, where he has more than 20 years of experience and currently heads the Stability, Submission Documents, and Information Systems Group. He is a member and past chair of the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) board of directors. He has chaired the Drug Product Technical Committee of the Product Quality Research Institute (PQRI). More recently, he helped form the International Consortium on Innovation and Quality in Pharmaceutical Development (IQ), served as the first chair of its board of directors, and is a member of the IQ Statistics Leadership Group.

Can’t attend?  If you register for a webinar but can't attend the live event, an archived version will be accessible online for 30 days once it concludes. This allows you to view the entire webinar presentation and Q&A session at a time most convenient to your schedule.

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