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Safety pharmacology--a progressive approach
William S Redfern1, Ian D Wakefield, Helen Prior
1Safety Assessment UK, AstraZeneca R & D Alderley Park, Cheshire, UK. Will.Redfern@astrazeneca.com
Fundamental & Clinical Pharmacology
|August 8, 2002
Summary
Integrating safety pharmacology studies early and strategically throughout drug discovery can significantly reduce clinical trial failures and accelerate the delivery of safer medicines.
Area of Science:
- Pharmacology
- Drug Discovery
- Clinical Trials
Background:
- Adverse drug reactions (ADRs) are a significant cause of drug attrition and mortality.
- Current preclinical safety assessment has room for improvement.
Purpose of the Study:
- To propose a streamlined, step-wise approach to safety pharmacology (SP) integrated throughout drug discovery.
- To enhance informed decision-making at preclinical milestones.
- To reduce clinical development attrition and market safer drugs faster.
Main Methods:
- Implementing a strategic, early-stage safety pharmacology testing program.
- Selecting and validating robust, reliable in vitro and in vivo SP tests.
- Establishing outcome criteria with acceptable safety margins for risk assessment.
Main Results:
- Early SP data can guide compound selection and predict clinical ADR risks.
- Strategic SP can help define therapeutic windows for human dosing.
- Improved preclinical safety assessment leads to reduced attrition.
Conclusions:
- A smart, integrated safety pharmacology approach is crucial for efficient drug development.
- Early and predictive SP testing contributes to marketing safer medicines more rapidly.
- Optimized SP strategies enhance the overall safety profile of new drugs.