Healthy Normal vs. Patient Volunteers & Sample Size Determination & Number Of Cohorts
Jeffrey S. Litwin, MD
Executive Vice President and Chief Medical Officer
eResearchTechnology, Inc.
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Audio-only
Number and Timing of Readings & Choosing the Right Dose
Lawrence Z. Satin, MD, FACC
Chief Medical Officer
Cardiocore
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Audio-only
The Clinical Operational Execution Approach of TQT Trials
Alan Copa, PharmD
President – Fargo & East Grand Forks
Cetero Research
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Audio-only
Open Exchange Audio |
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The Cadaver Skin Permeation Assay:
A Valid Surrogate for BA/BE Assessment – Fundamentals of the cadaver skin assay
focusing on in-vitro/in-vivo correlation
Paul A. Lehman, MSc
Director, Clinical and Pre-clinical Dermatology
Cetero Research
Critique/Conclusion
Brief critique by Dr. Annette Bunge (CSM)
and Dr. Gerald B. Kasting (UC)
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Audio
Role of Cadaver Skin Permeation Assay in New and Generic Drug Development – The Critical Path Initiative and using the
assay in the drug development process
Thomas J. Franz, MD
Executive Medical Director, Dermatology
Cetero Research
Critique/Conclusion
Brief critique by Dr. Annette Bunge (CSM)
and Dr. Gerald B. Kasting (UC)
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Audio |
