Trends in USP4 Flow-through Dissolution Science: Complex and Long-Acting Parenteral Dosage Forms
Hourly Schedule
Agenda
- 11:30 am - 11:35 am
- Welcome
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Speakers:
Deanna Mudie
- 11:35 am - 11:40 am
- Introduction of Speaker Qiuhua Qin by the Session Chair
-
Speakers:
Vivek Shah
- 11:40 am - 12:25 pm
- BioJect: Enabling the Future of Subcutaneous Delivery Through Precision Peptide Release Studies
-
Speakers:
Qiuhua Qin
- 12:25 pm - 12:30 pm
- Introduction of Speaker Nilesh Malavia
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Speakers:
Vivek Shah
- 12:30 pm - 01:15 pm
- Advancements into the In-Vitro Release Testing of Long Acting Parenterals
-
Speakers:
Nileshkumar Malavia
- 01:15 pm - 01:30 pm
- Panel Discussion. Questions and Answers
-
Speakers:
Vivek Shah
Speakers
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Deanna Mudie
Dr. Deanna Mudie is a leader in oral drug formulation and PBPK modeling with over 20 years of experience across academia, pharmaceutical companies, and CDMOs. She is a recognized expert in the development of amorphous solid dispersion (ASD) formulations for improving the performance of poorly soluble compounds. As a Senior Principal Scientist at Simulations Plus, Dr. Mudie develops modeling solutions that enhance drug innovation and streamline regulatory approvals. With a PhD in Pharmaceutical Sciences and a BSE in Chemical Engineering from the University of Michigan, she combines her background in formulation design with simulation technology to advance pharmaceutical research.
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Nileshkumar Malavia
University of Connecticut, Student of Dr. Diane Burgess to discuss novel adaptor work that fits into compendial systems to load suspensions and simulate in vivo conditions.
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Qiuhua Qin
National University of Singapore, Student of Dr. Matthias G. Wacker to discuss newly released BioJect. A novel adaptor that is designed for the Apparatus 4 to simulate diffusion through a custom agarose gel to mimic in vivo conditions.
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Vivek Shah
Vivek Shah is a highly accomplished scientist with an academic background in pharmaceutical sciences and chemistry. He received his Bachelor’s degree in Pharmaceutical Sciences from Ohio State University and then pursued a Master’s degree in Chemistry from Long Island University.
After completing his studies, Vivek began his professional career at Merck. He contributed to the development of new techniques, Direct Drug Analysis in Polymeric Implants DESI-MSI Imaging and using Mixed Reality in Pharmaceutical Development. His expertise with the Apparatus 4 helped drive dissolution studies for many different programs including a program that used an in-line NMR cryoprobe with the Apparatus 4.
Vivek’s expertise and contributions to the pharmaceutical industry have not gone unnoticed. He currently serves on the USP expert panel for In Vitro Product Performance and is an Executive Board member for the US Society of Pharmaceutical Dissolution Science, demonstrating his commitment to advancing the field of pharmaceutical sciences and his deep understanding of in vitro testing methodologies.
Currently, Vivek is leading the Pharma Services team for SOTAX in Massachusetts, where he continues to demonstrate his leadership and scientific acumen. In his current role, he has helped develop and validate groundbreaking in-vitro methods for complicated drug release programs.