Dennis Sandell, PhD
Dr Dennis Sandell holds a Licentiate of Science in Mathematical Statistics (1990, U. of Lund, Sweden). He has worked for AstraZeneca, Amgen and Siegfried Pharma Development GmbH in both specialist and management roles and is currently an Adjunct Professor at the Department of Pharmaceutics, University of Florida.
Dr Dennis Sandell is a leading expert in the area of CMC statistics, especially related to development, registration and commercial manufacture of inhalation products. He has a special interest in and long experience of in-vitro bioequivalence as well as correlating in-vitro data with results from pharmacokinetic studies). He has deep experiences from of a wide range of innovator and generic DPIs, MDIs, nasal sprays and nebulization products, as well as different respiratory add-on devices.
Dr Dennis Sandell has 100+ publications and frequently presents at international conferences. He has participated in different industry collaborations such as IPAC-RS, EPAG, PQRI and PhRMA and is a member of USP Statistics Expert Committee, chair of the USP Large N Expert Panel and member of the USP Data Analysis subcommittee.
In May 2010 Dr Dennis Sandell started the consulting firm S5 Consulting, providing CMC statistical support, general inhalation development advice, regulatory writing, and due diligence assistance.