Skip to main content

Dissolution in Pharmacopeias

Description

10:00 AM – 10:05 AM
Introduction and Welcome
Xujin Lu, Ph.D., Bristol-Myers Squibb

10:05 AM – 10:15 AM
Industrial Survey and the Purpose of the Workshop
Mark Alasandro, Ph.D., Senhwa Biosciences

10:15 AM – 10:35 AM
USP <711> Dissolution
Margareth Marques, Ph.D., U.S. Pharmacopeia

10:35 AM – 11:00 AM
CHP International Harmonization Effort and Status
Baoming Ning, Ph.D., National Institutes for Food and Drug Control

11:00 AM – 11:25 AM
Rationale of CHP <931> Dissolution Testing and Criteria
Xiyi Xu, Ph.D., National Institutes for Food and Drug Control

11:25 AM – 11:50 AM
USP 711 vs CHP 931 Dissolution Acceptance Criteria Comparison and
Challenges to the Industry
Fasheng Li, Ph.D., Pfizer

11:50 AM – 12:25 PM
The Pharmacopeial Harmonization Process
Kevin Moore, Ph.D., U.S. Pharmacopeia

12:25 PM – 12:30 PM
Closing Remarks

Contributors

  • Mark Alasandro, Ph.D.

    Dr. Mark Alasandro, a Director in Analytical R&D, has led research teams at Allergan, Merck and DuPont. He has overseen and led method development, validation and stability teams developing products from early ‘first-in-man’ studies through commercialization. He has directed multiple registration stability studies and global approvals. As past chair of the PhRMA Stability Working Group, he supported several initiatives to enhance product quality through QbD approaches. He is the co-chair of the AAPS Steering Stability Focus Group Committee and the Planning Committee that developed the current and past AAPS Stability Workshops. Mark has a Ph.D. in Analytical Chemistry, and he has numerous publications and presentations in new analytical technologies, QbD and accelerated stability modeling approaches and strategies to support global registrations.

  • Margareth Marques

  • Baoming Ning

    Dr. Baoming Ning is Director of Antibiotics Division, National Institutes for Food and Drug Control (NIFDC). Dr. Ning has been active in teaching, research and service throughout his career. In 2009, he was appointed the member of the National Drug Standard Expert Committee. He became the member of WHO International Chemical Reference Substances (ICRS) board in 2012. Dr. Ning is an elected member of the Chinese Pharmaceutical Commission Reference Standard Expert Committee, English edition of Chinese Pharmacopoeia and Chinese edition of United States Pharmacopoeia.
    He has more than 25 years of experience in the pharmaceutical industry, university and official control laboratory. Baoming began his career as an Technical Director in Peking University Experimental Pharmaceuticals in 1992 and then joined the faculty of the School of Pharmaceutical Sciences at the Peking University in 1995 as Assistant. Since joined NIFDC in 1999, Dr. Ning has held positions in the drug registration testing, monographs elaboration, quality study, GMP.
    Reference Standard, Inhalation Preparations, Dissolution technology, Biopharmaceutics and IVIVC are Dr. Ning’s major research areas, he is also the team leader or key scientist for various National /Chinese Pharmacopoeia projects on quality study and regulatory science.

  • Fasheng Li

  • Kevin Moore

August 16, 2022
Tue 10:00 AM EDT

Duration 2H 30M

Already Registered?
For Technical Support
(888) 705-6002
+1 (858) 201-4136*
*for callers residing outside of the United States