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May 1, 2020

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

Introduction

The second joint workshop sponsored by the American Association of Pharmaceutical Scientists
(AAPS) and the Chinese National Institutes for Food and Drug Control (NIFDC) took place in Yantai, China, from May 31 to June 1, 2019. The theme of the workshop was Dissolution, Bioequivalence, Product Performance, and Quality.

Following the success of the first AAPS/NIFDC cosponsored workshop in 2016, this workshop aimed to meet the strong demand from local communities by addressing the following objectives: (1) enhance the
communication among Sino and American regulators, academics, and industry scientists in the field of in
vitro drug release; (2) share knowledge in dissolution methodology, new apparatus and technology, novel drug
formulation performance, and drug specification settings; (3) disseminate regulatory and compendia information
to facilitate method development, current Good Manufacturing Practice (cGMP) compliance, and quality control of drug products; and (4) facilitate networking and collaboration among scientists from the drug control and
inspection agencies, academia, and the pharmaceutical industry.

The workshop was organized by AAPS In-Vitro Release and Dissolution Testing (IVRDT) Community, Chinese Journal of New Drugs, and Shandong Institute 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-Acting and Targeting Drug Delivery System, Yantai Institute for Food and Drug Control, the Chinese Journal of Pharmaceutical Analysis, and the School of Pharmacy at Yantai University.

By Xujin Lu1, Baoming Ning, Nikoletta Fotaki, Sandra Suarez Sharp, Diane Burgess and Samir
Haddouchi

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