Dr. Guenther Hochhaus
Professor at University of Florida
Dr. Guenther Hochhaus received his Ph.D. in 1984 at the Institute of Pharmaceutical Chemistry, Westf. Wilhems University (Münster, Germany). He completed a postdoctoral fellowship at the University of California-San Francisco and subsequently joined the University of Florida’s College of Pharmacy. Dr. Hochhaus’ research is interested in evaluating inhalation drugs through in vitro, pharmacokinetic and pharmacodynamics approaches. Dr. Hochhaus is a Fellow of AAPS and the American College of Clinical Pharmacology. He has published more than 200 research papers.
Title: Challenges and potential solution for a streamlined development of generic inhalation drugs
- Approval of generic inhalation drugs remains a challenge. At this time, the FDA is suggesting a weight of evidence approach that compares in vitro characteristics of the generic and innovator formulation, pharmacokinetics to primarily assess systemic safety, as well as biomarker/clinical studies to ensure equivalence of efficacy
- Biomarker/clinical studies are challenging and represent a large financial risk due to the generally observed flat dose-response relationship, distinct variability, and the large number of patients required for such clinical trials without providing sufficient high resolution in detecting differences in the pulmonary equivalence. A method to assess local equivalence with high resolution and lower costs is therefore urgently needed
- This talk will review and discuss potential alternative approaches for the development of generic inhalation drugs