Setting the Stage: Respiratory Drug Development Nonclinical Components

• Drug substance/Drug Product- What do you need to know and have available before stating an IH tox program
• Formulation selection / development for inhalation programs 
• Solutions, suspensions, MDI, dry powders, engineered dry powders
• Inhalation Devices – nebulizers, dry powders, pMDI’s, non-clinical and clinical generation systems
• The basics to starting an inhalation drug development program 
• Understanding Inhalation dose and how to merge dose from different delivery routes 
• Inhalation exposure systems: chambers (rodent, dog, NHP, insufflator) - Aerosol data - concentration, MMAD, data analysis/review 
• Impactors, filters, bubblers APS, etc.
• Physiology Data-configuration, design and interpretation for respiratory, CV and neuro
• The role of a study director: writing a study protocol, interacting with clients, managing the study and expectations 
• Study design: MTD, dose range finding, GLP, regulatory expectations including species selection.
• Key endpoints in a toxicology program
• Clinical chemistry/Hematology
• Physiology - Clinical obs/body weights/food consumption 
• Dose formulation and Bioanalytical-  Tox Data Review (Statistical versus Biological Significance)
• Intratrachael/Intranasal extrapolation / devices / practicality / limitations or not
• Compliance - what is 21 CFR Part 58 and its application towards aerosol studies
• Bioanalytical and Pharmacokinetics Analysis and Considerations
• Clinical Pathology: Interpretation and Use
• Histopathology: Adverse vs. non-adverse pathology findings with pathology slides
• Interacting with Regulatory Authorities (unique aspects of respiratory)

Agenda Topics (Hands-on)

• Protocol Review
• Aerosol systems (hands-on exercises)
• Physiology-(hands-on exercises)
• PK/TK (hands-on exercises)

More Information

• Venue: Sandia Resort, Albuquerque NM
• Dates: September 8-11 (Sept. 8 only evening reception)
• Included: Breakfast and Lunch