WORKSHOP
Dissolution, Bioequivalence, Product Performance and Quality
May 30-June1, 2019(May 30 Registration)
Location: | Orient Haitian Hotel Yantai,Shandong,China |
Workshop | Dr. Xujin Lu |
Chairs: | Dr. Baoming Ning |
Organizing | AAPS In-Vitro Release & Dissolution Testing Community |
Committee: | Chinese National Institute for Food and Drug Control |
Shandong Institute for Food and Drug Control | |
Yantai Administration for Market Regulation | |
Yantai Institute for Food and Drug Control | |
Chinese Journal of New Drugs | |
Chinese Journal of Pharmaceutical Analysis | |
Objectives: | |
The goal of this workshop is to discuss the following aspects and enable the attendees: | |
1.Use of dissolution as a tool for drug development, biowaiver, and bioequivalence studies. | |
2.Share Chinese research activities and collaborations in dissolution, apparatus calibration, bioequivalence, and drug specification setting topics. | |
3.Learn international current trend, hot topics, and new methodologies and technologies in dissolution and drug release studies and applications. | |
4.Disseminate Chinese regulatory information for dissolution testing and bioequivalence. Understand the drug inspection policies that are related to dissolution in drug product development, cGMP, SUPAC, and generic product quality. | |
LECTURE SCHEDULE | |
Day 1:May 31st,2019 | |
8:15 - 8:30 | Opening remarks |
Session Theme: Dissolution - International Trends and New Regulation (Moderator: Dr. Xujin Lu) | |
Learning Objectives: | |
1.Introduction to new dissolution guidelines from international health authorities | |
2.Presentation of Chinese drug evaluation agency policy and practice on drug product quality | |
3.Dissemination of regulatory information for dissolution testing and biowaiver | |
8:30 - 9:15 | FDA guideline and regulatory perspective to the quality, quality evaluation of solid oral dosage drug products, dissolution testing and biowaiver. |
Speaker: | Dr. Sandra Suarez (FDA, AAPS member) |
9:15 - 10:00 | Chinese Drug Evaluation (CDE) agency requirement and perspective to the quality and quality evaluation of solid oral dosage drug products. |
Speaker: | Prof. Wang Yamin (CDE, China) |
10:00 - 10:30 | Break |
10:30 - 11:15 | Dissolution apparatus in Chinese Pharmacopoeia and compliances |
Speaker: | Dr. Baoming Ning (NIFDC) |
11:15 - 12:00 | Application of USP apparatus 4 |
Speaker: | Dr. Diane J. Burgess (University of Connecticut, AAPS Member) |
12:00 - 12:15 | Question & answer session – Panel discussion |
Moderator: | Dr. Xujin Lu |
12:15 - 1:15 | Lunch |
Session Theme: Dissolution Technologies and Implementation (Moderator: Dr. Baoming Ning) | |
1.Introduction to USP dissolution devices and methodologies | |
2.Digest the case studies relative to the applications of USP dissolution apparatus | |
3.Presentation of new technology that enhance the understanding of drug release mechanisms | |
1:15 - 1:30 | Introduction to American Association of Pharmaceutical Scientists (AAPS), the In Vitro Drug Release and Dissolution Testing (IVRDT) Community, and related activities. |
Speaker: | Dr. Xujin Lu (BMS, USA,AAPS member) |
1:30 - 2:15 | Application of USP apparatus 4, case studies |
Speaker: | Dr. Nikoletta Fotaki (U of Bath, UK, AAPS member) |
2:15 - 3:00 | Application of 3D Image Technology in Drug Development |
Speaker: | Dr. Liu Zhen (MSD, USA) |
3:00 - 3:30 | Break |
3:30 - 4:15 | Key Framework Technologies in the Characterization and Optimization of Microstructures in Drug Release System |
Speaker: | Shawn Zhang (DigiM, USA) |
4:15 - 5:00 | Application of Spectroscopic Imaging Technologies to Dissolution and Formulation Development. |
Speaker: | Dr. Xujin Lu (BMS, USA, AAPS Member) |
5:00 - 5:15 | Question & answer session – Panel discussion |
Moderator: | Dr. Baoming Ning |
5:30 - 7:00 | Dinner |
7:00 - 9:00 | Technology exchange |
Day 2:June 1st,2019 | |
Session Theme: Biorelevant, In Vivo Predictive, and Clinical Relevant Dissolution (Moderator: TBD) | |
Learning Objectives: | |
1.Review IVIVC requirements, methodologies and applications | |
2.Dissemination of the considerations and perspectives from regulatory agencies | |
3.Critical aspects of clinical relevant dissolution specification | |
4.Points of dissolution for API characterization and formulation development | |
8:15 - 9:00 | In vivo predictive dissolution and IVIVC |
Speaker: | Dr. Johannes Kramer (PHAST, Germany, AAPS Member) |
9:00 - 9:45 | Establishing Clinically Relevant Dissolution Specifications --- Possible |
Speaker: | Dr. Sandra Suarez (FDA, AAPS member) |
9:45 - 10:15 | Break |
10:15 - 11:00 | Application of dissolution technology in API quality characterization. |
Speaker: | Samir Haddouchi (SPS, France) |
11:00 - 11:45 | Impact of drug-excipient moleculear interaction on the dissolution performance and bioavailability of supersaturable fomulations |
Speaker: | Prof. Qian Feng (Tsinghua University,AAPS member) |
11:45 - 12:00 | Question & answer session - Panel discussion |
Moderator: | TBD |
12:00 - 1:00 | Lunch |
Session Theme: Emerging topics in dissolution and challenges (Moderator: TBD) | |
Learning Objectives: | |
1.Recognition of the challenges from new drug delivery and new manufacturing process | |
2.Introduction of modeling for RTRT and PBPK based modeling in support of drug product development | |
3.Presentation of new concepts and methodologies to prepare for the new challenges | |
1:00 - 1:45 | RTRT needed predictive and clinically relevant dissolution models for continuous manufacturing |
Speaker: | Dr. Xujin Lu (BMS, USA, AAPS Member) |
1:45 - 2:30 | PBPK based modeling and simulation in support of drug product development |
Speaker: | Dr. Nikoletta Fotaki (University of Bath, AAPS Member) |
2:30 - 3:00 | Break |
3:00 - 3:45 | Drug release from long acting biodegradable microspheres of injectables |
Speaker: | Dr. Diane J. Burgess (University of Connecticut, AAPS Member) |
3:45 - 4:30 | Application of In Vitro Dissolution Technology in Development for Modified Release Dosage Forms |
Speaker: | Dr. Li Youxin (Shandong Luye Pharma Group) |
4:30 - 4:45 | Question & answer session – Panel discussion |
Moderator: | TBD |
4:45 - 5:00 | Closing remarks |
Dr. Xujin Lu and Dr. Baoming Ning |
2019年05月31日-2019年06月01日
2019年5月29日
2019年5月30日