42 MAY 2020 www.dissolutiontech.com INTRODUCTION T he second joint workshop sponsored by the American Associaton of Pharmaceutcal Scientsts (AAPS) and the Chinese Natonal Insttutes for Food and Drug Control (NIFDC) took place in Yantai, China, from May 31 to June 1, 2019. The theme of the workshop was Dissoluton, Bioequivalence, Product Performance, and Quality. Following the success of the frst AAPS/NIFDC cosponsored workshop in 2016, this workshop aimed to meet the strong demand from local communites by addressing the following objectves: (1) enhance the communicaton among Sino and American regulators, academics, and industry scientsts in the feld of in vitro drug release; (2) share knowledge in dissoluton methodology, new apparatus and technology, novel drug formulaton performance, and drug specifcaton setngs; (3) disseminate regulatory and compendia informaton to facilitate method development, current Good Manufacturing Practce (cGMP) compliance, and quality control of drug products; and (4) facilitate networking and collaboraton among scientsts from the drug control and inspecton agencies, academia, and the pharmaceutcal industry. The workshop was organized by AAPS In-Vitro Release and Dissoluton Testng (IVRDT) Community, Chinese Journal of New Drugs, and Shandong Insttute for Food and Drug Control. This event was supported by the Medical Instrument Branch of China Instrument and Control Society, State Key Laboratory of Long-Actng and Targetng Drug Delivery System, Yantai Insttute for Food and Drug Control, the Chinese Journal of Pharmaceutcal Analysis, and the School of Pharmacy at Yantai University. SESSION ONE The Chair of the Organizing Commitee, Dr. Xujin Lu (Bristol Myers Squibb, USA) welcomed partcipants and gave an introducton to the motvaton and aims of the workshop, referencing the previous workshop. In the opening session, the workshop started with disseminaton of regulatory guideline and perspectve on drug product quality and dissoluton testng. Dr. Sandra Suarez Sharp (United States Food and Drug Administraton [FDA]) delivered the frst lecture enttled “The Role of Biopharmaceutcs Tools in Support of Drug Product Quality and Regulatory Approval: FDA Perspectve.” She emphasized that biopharmaceutcs ensures that drug release and absorpton from the drug product results in optmal therapeutc efcacy and safety for the patent. Tools used in biopharmaceutcs such as bioavailability (BA) and bioequivalence (BE) measures are employed to provide a linkage between changes in the critcal material atributes (CMAs), critcal process parameters (CPPs), and clinical outcomes supportng patent-centric drug product quality. Without a dissoluton method that increases the likelihood of developing a successful in vitro-in vivo American Association of Pharmaceutical Scientists (AAPS) and Chinese National Institutes for Food and Drug Control (NIFDC) Joint Workshop on Dissolution, Bioequivalence, Product Performance, and Quality Xujin Lu 1* , Baoming Ning 2 , Nikoleta Fotaki 3 , Sandra Suarez Sharp 4,5 , Diane Burgess 6 and Samir Haddouchi 7 1 Bristol Myers Squibb Company, New Brunswick, NJ, USA. 2 Natonal Insttutes for Food and Drug Control, Beijing, China. 3 University of Bath, Bath, UK. 4 Center for Drug Evaluaton and Research, Food and Drug Administraton, Silver Spring, Maryland, USA. 5 Current: Simulatons Plus Inc., Lancaster, CA, USA. 6 University of Connectcut, Storrs, CT, USA. 7 SPS Pharma Services, Orléans, France. dx.doi.org/10.14227/DT270220P42 e-mail: xujin.lu@bms.com *Corresponding author