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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)
Session Co-Chair
Kathy Kemme
Camargo Pharmaceutical Services, United States
Associate Director of CMC Services
Challenges in Developing Dissolution Methods for Non-Conventional Suspensions, Implants, and Stents
Vivian A Gray
V.A. Gray Consulting, LLC, United States
President
Statistics for Dissolution Methods for Novel Dosage Forms/Non-Biologic Complex Drugs
Helen Naylor Strickland
GSK, United States
Senior Statistical Consultant
Regulatory Challenges for Dissolution Methods for Novel Dosage Forms/Non-Biologic Complex Drugs
Okpo Eradiri, PhD
FDA, United States
Acting Quality Assessment Lead