Chapter 2. Microdosing and Clinical Pharmacology
2.1 The Benefit of Early Human Pharmacodynamic Information
2.2 Expected Relations between Microdoses and Clinically Effective Doses
2.3 Microdosing Known Compounds to Assess Investigational Drug Effects
2.4 Bioanalytical Support: Constraints and Perspectives
-Accelerator Mass Spectrometry
-Tandem Liquid Chromatography/Mass Spectroscopy
-Positron-Emission Tomography
2.5 Using Microdosing-Type Analytical Methods in Safety Pharmacology

Chapter 3. Microdosing Studies as a Strategic Tool
3.1 Microdosing as a Tool to Weigh Drug Development Options
3.2 A Fruitful Marriage with in silico Optimization Techniques and “-omics”
3.3 Option for Studies in Unconventional Populations

Chapter 4. Microdosing as a Regulatory Challenge and Opportunity
4.1 The EMEA Position Paper on Microdosing
4.2 The FDA Exploratory IND Guideline
4.3 Other Regulatory Guidelines for Studies Using Radioactive Drugs
4.4 Benefits in Costs, Time, and Logistics
4.5 The Ethical Aspect: Reducing the Burden on Volunteers and the Use of Animals

Chapter 5. Practical Experience and Planning-Stage Projects with Microdosing
5.1 Proof of Concept through In Vitro and Animal Studies
5.2 Collaborative Industry and Public/Private Efforts
-The Consortium for Resourcing and Evaluating AMS Microdosing
-Azidothymidin Study by Radiant Research and Vitalea Sciences
-The EU Microdose AMS Partnership Programme (EUMAPP)
5.3 Pharmaceutical Companies as Sponsors of Microdosing Studies
-GlaxoSmithKline
-Servier
-Speedel Pharmaceuticals
-Tripep
-Neurocrine Biosciences
-Industry Opinions on the Acceptance of Microdosing

Chapter 6. Expert Roundtable Commentaries
Dr. Ali Arjomand, President and COO, Accium Biosciences
Dr. Stephen Dueker, President, Vitalea Science
Dr. Jon Ruckle, Medical Director, Early Phase Research, Radiant Research
Dr. Lloyd Stevens, Business Support Manager, Pharmaceutical Profiles
Prof. Dr. Colin Garner, CEO, Xceleron

Question 1: Do you see possibilities for modifying current microdosing protocals to make them more predictive?
Question 2: Do you see additional potential in evaluating other parameters relevant to drug development, such as drug interactions?
Question 3: How do you estimate the potential of isotopes other than 14C?
Question 4: How do you see the relationship between AMS and LC/MS/MS developing?
Question 5: What role do you see for imaging technologies, expecially PET, in microdosing studies?
Question 6: Could human microdosing be accepted to such an extent that it becomes a routine screening tool for drug leads in a streamlined clinical development process?
Question 7: Could you comment on the potential feedback loops between human microdosing studies, the various “-omics,” and in silico methods?
Question 8: Do you see opportunities for microdosing in formal preclinical study programs?
Question 9: With EMEA and FDA guidelines in place, how do you think the scenery will develop geographically during the next few years?
Question 10: What are your optimistic and pessimistic estimates for the dollar volume of the microdosing market by 2010 and 2015?
Question 11: What share of this market do you estimate your company will capture by 2010 and 2015?

Chapter 7. Conclusion: Cambridge Healthtech Associates’ Scenario for Microdosing in Drug Development
7.1 Today’s Outlook Depends on Where You Are in the Drug Development Process
7.2 Along the Way: Getting Over Nonscientific and Noneconomic Factors
7.3 An Exciting New Tool

Appendix A. Companies Offering Microdosing Services

Appendix B. Cambridge Healthtech Associates - Microdosing Survey – April 2006-04-24

References

Company Index with Web Addresses