Microdosing in Translational Medicine: Pros and Cons evaluates this innovative approach to investigating candidate molecules.

The CREAM trial and other studies have largely validated the concept of human microdosing (HMD) as a reliable screen for basing go/no go decisions to Phase I. CHI predicts human microdosing (HMD) will first be used by smaller drug developers with limited resources, finding broader acceptance by the industry as a routine “litmus test” by 2012. Orest Hurko, AVP of Translational Research at Wyeth, expects 75% of biopharma companies to implement it over the next 5 years.

Microdosing in Translational Medicine: Pros and Cons provides a balanced evaluation of the pros and cons of HMD, including:

• What the CREAM trial and other HMD studies say about the linearity of PK results.
• Comparative assessment of EMEA and FDA guidelines governing HMD — which offers the more hospitable pathway?
• Use of HMD in synergy with in silico and other predictive technologies.
• Assessment of current detection technologies and emerging improvements.
• Use of PET in HMD to study ligand displacement.
• Which sector will adopt HMD first --- big pharma or biotechs?
• Applications of HMD using oral, IV, and other routes of administration.
• Examination of cost-benefit, risk management, regulatory and ethical aspects of HMD.

Microdosing in Translational Medicine: Pros and Cons is based upon:

• Roundtable interviews with CEOs of the leading CROs specializing in HMD.
• A survey of the views, actions and planned activities of R&D managers at pharma and biotech companies with responsibility for selecting candidates for Phase I.
• Forecast of the market for HMD services and timelines to adoption by pharma and biotech companies.
  

About the Author

Hermann A.M. Mucke, Ph.D. spent 17 years in academia and industry before he founded H.M. Pharma Consultancy (www.hmpharmacon.com) in 2000 to become an independent pharmaceutical consultant, analyst and science author. His last industry position was Vice President R&D in a European pharmceutical company which he helped to take public on the Frankfurt Stock Exchange in 1999. Since then, Dr. Mucke, who holds a Ph.D. in biochemistry from the University of Vienna (Austria) became a consultant and advisory board member for several European and U.S. pharmaceutical companies, and a regular reviewer of drugs and patents for Thomson Current Drugs and Ashley Publications. He has served as an outside expert author for CHI since 2004. Dr. Mucke is based in Vienna and can be reached at h.mucke@hmpharmacon.com , or by fax at +43 1 494 9989.