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Session 4B: Dissolution Techniques Challenges
Session Chair(s)
Lynn Gold, PHD
Vice President of Scientific and Regulatory Affairs, Camargo Pharmaceutical Services, LLC, United States
Innovation is essential to the development of novel pharmaceutical drug products, such as Non-Biologic Complex Drugs (NBCDs), such as nanoparticles, microspheres, parenterals and suspensions, which present unique challenges to the development program, impacting the design of a meaningful dissolution method. There are many challenges to dissolution for the standard drug products and the drug product complexity increases the dissolution method challenges become more complex as well. The challenges take many forms such as sampling, apparatus, parameters, optimum statistical analysis and regulatory acceptability. This session will explore various aspects of these challenges from historical, scientific and regulatory perspectives.
Speaker(s)
Kathy Kemme
Associate Director of CMC Services, Camargo Pharmaceutical Services, United States
Session Co-Chair
Vivian A Gray
President, V.A. Gray Consulting, LLC, United States
Challenges in Developing Dissolution Methods for Non-Conventional Suspensions, Implants, and Stents
Helen Strickland
Senior Statistical Consultant, Retired, United States
Statistics for Dissolution Methods for Novel Dosage Forms/Non-Biologic Complex Drugs
Okpo Eradiri, PHD
Acting Quality Assessment Lead, FDA, United States
Regulatory Challenges for Dissolution Methods for Novel Dosage Forms/Non-Biologic Complex Drugs
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