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个人简介
Yihong Qiu currently serves as the Technical Director and Founder of QPD Solutions LLC, a technical service company that specializes in providing a broad range of scientific and technical expertise, hands-on guidance and trainings for science-based efficient design, development, and commercialization of pharmaceutical products & processes. Prior to establishing QPD Solutions in 2022, he was a Senior Research Fellow in Formulation Sciences at AbbVie. His in-depth knowledge and extensive experience encompass multiple key stages of the drug product lifecycle, including preformulation, product/process design, drug delivery technology, biopharmaceutics & pharmacokinetics, formulation & process development, scale-up, technology transfer, marketed product support, IP, regulatory filing for NCEs, line-extension products and post-approval changes. During his 30-year tenure with Abbott/AbbVie, he was the go-to expert for the Product Development, Manufacturing Science & Technology, RA-CMC, Dissolution, and Legal departments. His contributions have not only led to successful blockbuster IR and MR products, but also had significant scientific and business impact on numerous commercial and pipeline drug products through creating new products & processes, solving difficult technical problems, improving and trouble-shooting commercial product/process, developing IVIVC’s and biowaivers accepted by global regulatory agencies. He also served as a technical SME in the product LCM, IP strategy, and scientific and regulatory assessment of business opportunities for the company for over two decades.
Dr. Qiu is a recognized expert in pharmaceutical research & development. His research interests focus on modified-release delivery, formulation/process technologies for enhancing dissolution and bioavailability of insoluble drugs, dissolution, IVIVC, drug delivery technology, and science-based regulatory filing. He is an elected fellow of the American Association of Pharmaceutical Scientists (AAPS) and a member of the USP Expert Committee (2010-15). He has more than 60 publications and book chapters, over 35 patents granted or pending, and numerous invited presentations at conferences, universities, and regulatory agencies. As the lead editor, he designed the reference book Developing Oral Dosage Forms: Pharmaceutical Theory and Practice (1st ed. in 2009, 2nd ed. in 2016, and 3rd ed. in preparation), which is widely used by development scientists, graduate programs, and FDA CMC reviewers. Notable awards he has received include R&D President Awards, the LCM Innovation Award, Publication of the Year Awards, and the Corporate Scientific Governing Board (SGB) Innovation Award. Dr. Qiu received his B.S. in Pharmacy and M.S. in Pharmaceutics from China Pharmaceutical University and his Ph.D. in Pharmaceutics from the University of Iowa.
研究兴趣
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Shanghai of Biomedical Engineeringno. 1 (2023)
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