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Repositioning ADME Studies: A Strategy to Reduce Drug Attrition
Decision Resources, Inc, January 2007, Pages: 19
More effectively evaluating a broad range of a drug’s ADME properties during the early stages of the R&D process provides an opportunity to reduce clinical failure rates. This approach can enable researchers to eliminate poor drug candidates early on, thereby substantially reducing the overall cost and risk of drug development.
Get the Answers You Need to Shape Your Strategy
-Even though drug developers are spending more resources on R&D, the number of drugs approved each year is not increasing and the cost of development continues to rise.
-What role do ADME properties of drugs play in their success or failure? How can developers lower the attrition rate by moving ADME studies to earlier in the development process?
-Repositioning of ADME studies and the use of new methodologies allow companies to terminate unsuitable compounds, which improves R&D efficiency.
-What screening tools are available and how can they help determine viability of a compound so early in the development process?
-Outsourcing some or all of ADME testing is likely to be the preferred option for many developers, especially smaller companies, and the choice of service provider is a significant strategic decision.
-What commercial opportunities are available for ADME testing service providers, and what steps are these companies taking to create better, more useful ADME assays?
-ADME properties: descriptions of the four categories of ADME: absorption, distribution, metabolism, and excretion.
-Positioning in R&D process: Benefits of moving ADME studies to earlier in the drug development process.
-Company profi les: companies that provide ADME screening services and tools to the pharmaceutical industry, including Apredica Creative Research Solutions, and TechElan.
-Outlook: how will companies implement ADME strategies in the future and what new tools will become available?
Executive Summary 3
Strategic Considerations 3
Stakeholder Implications 3
ADME Properties and Drug-Likeness 5
Positioning ADME in the R&D Process 5
Experimental Methods 7
Cell-Culture Assays 7
Cell-Free Assays 7
Computational Methods 8
Protein Binding 8
Blood-Brain-Barrier Penetration 8
Experimental Methods 9
Computational Methods 10
Company Profi les 11
Creative Research Solutions 11
Nimbus Biotechnology 15
Novamass Analytical 15
Quest Pharmaceutical Services 15
Solvo Biotechnology 15
Outlook for Early-Stage ADME Studies 16
1. Lipinski’s Rules 7
2. Suppliers of Computational ADME Packages 12
3. Providers of ADME Services 13
1 Success Rates as Compounds Advance Through Stages of Development 4
2. New Positioning of ADME Studies During Drug Discovery 6
Bayer Technology Services
Creative Research Solutions
MDS Pharma Services
Quest Pharmaceutical Services