Phase 1 Experience
Phase I therapeutic area experience -
Alzheimer's Disease
- Device Studies
- Diabetes - Type 1
- Diabetes - Type 2
- Diabetic Neuropathy
- Hypercholesterolemia/Dyslipidemia
- Osteoporosis/Osteopenia (male and female)
- Renal Insufficiency
Phase I type of study experience
- PK/PD
- Dose Finding
- Proof-of-Concept
- Bioequivalence
- Pivotal Safety and Efficacy
- Nerve Conduction
- Endpoint/Outcome
Phase I pharmacologic classes experience
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- Bisphosphonates
- Cathepsin K
- Continuous Glucose Monitoring
- DPPIV
- Glucagon-Receptor Antagonists
- Glucokinase Activators
- Incretins (GLP1)
- Inhaled Insulin
- Monoclonal Antibodies
- Rank-L
- VEGF
- Stearyl CoA-Dehydrogenase Inhibitors
Phase I Expertise in Glucose Clamp
-
Described by DeFronzo, Tobin, and Andres in 1979 to quantify insulin resistance and secretion
- Excel template developed by Dr. Christiansen, using DeFronzo equations, to assist with clamp studies
- Personally performed over 60 clamps, (30 individuals before and after intervention) from 120 to 240 minutes (Diabetes Care, 2000 23(7), p 1000-1005)
- Stable glucose levels within 60 minutes
- Program capable of different insulin elevations, depending upon the study
- Most studies were isoglycemic, program allows for this to be adjusted also
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