Developing Solid Oral Dosage Forms (ePub)

Associate Research Fellow, Volwiler Society. Dr. Chen also served as an expert member of both the Product Quality Research Institute (PQRI) and the USP Performance Testing Expert Panel, and as an adjunct professor at the Guangdong Pharmaceutical University. Dr. Chen has in-depth knowledge and extensive experience in various aspects of developing solid pharmaceutical products, ranging from formulation and process development, CMC documentation for regulatory filing, scale-up, and validation for commercialization. His expertise includes the quality by design (QbD) development of modified release (MR) products using traditional delivery technologies, and development of new delivery systems for MR products. Dr. Chen has extensive experience in the development and scale-up of beads coating process using Wurster coating technology for different types of products from lab to commercial scales. He has successfully led the development and secured the approval of more than 30 products approved in the US, EU, Japan and China, including new drug applications (NDAs) and high barrier branded abbreviated new drug applications (ANDAs). Dr. Chen also has the expertise in packaging protection of drug products. He developed a theoretical model for predicting moisture uptake by packaged products during storage. His theory provided the fundamental basis for the development of ASTM D7709 and the revision of USP general chapter on the standard methods for measuring the water vapor transmission rate (WVTR) of containers, as well as the scientific criteria of using MVTR/unit product to evaluate the performance of containers for product protection. Dr. Chen has published over 30 peer-reviewed articles, book chapters, and patents. He is a co-editor of “Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice. Dr. Chen is a frequent speaker at national and international conferences, and at major universities.

Dr. Geoff G. Z. Zhang is a Senior Research Follow at AbbVie Inc., an adjunct professor of the Department of Industrial and Physical Pharmacy at Purdue University, and a Fellow of the American Association of Pharmaceutical Scientists. He received his B.Sc. in Physical Chemistry from Fudan University, China, and Ph.D. in Pharmaceutics from the University of Minnesota, USA. He has contributed broadly to Physical Pharmacy, specifically in the areas of crystal engineering, polymorphism, characterization and crystallization of amorphous solids and amorphous solid dispersions, as well as delivery of poorly water soluble compounds. He has published over 70 peer-reviewed articles, reviews, and book chapters, given over 170 podium and poster presentations. During his 18-year tenure with Abbott/AbbVie, he has more than 120 granted patents and patent applications. He interacts and collaborates extensively with academic institutes and has mentored 40 graduate students on their thesis and summer research projects. He has received 2012 AAPS Pharmaceutical Research Meritorious Manuscript Award, and serves on the United State Pharmacopeia Physical Analysis Expert Committee.