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Trends in early drug safety
Richard E Armer1, Ian D Morris
1Oxagen Ltd, Oxon, UK.
Drug News & Perspectives
|April 21, 2004
Summary
Drug development is costly and risky, with a low success rate. Early assessment of absorption, distribution, metabolism, excretion, and toxicology (ADME-Tox) profiles is crucial for identifying viable drug candidates and improving success rates.
Area of Science:
- Pharmacology and Toxicology
- Drug Discovery and Development
Background:
- The pharmaceutical industry faces high costs and failure rates in drug development, with only about 1 in 10 candidates succeeding.
- Rising R&D costs contrast with stagnant new drug launch numbers, highlighting inefficiencies.
- A significant challenge is the absorption, distribution, metabolism, excretion, and toxicology (ADME-Tox) profile of drug candidates, leading to substantial investment losses.
Framework:
- Focus on early assessment of ADME-Tox properties to mitigate risks.
- Integration of drug safety evaluations early in the discovery and development process.
- Leveraging recent symposia findings on ADME and pharmacokinetic aspects.
Implementation:
- Discussing classical toxicology approaches.
- Examining cytochrome P450-mediated safety and cardiovascular safety.
- Exploring the impact of 'omics' approaches on clinical safety predictions.
Implications:
- Improved selection of drug candidates for clinical development.
- Potential to reduce the high failure rates in pharmaceutical R&D.
- Enhancing the efficiency and success of bringing new drugs to market.