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Safety Pharmacology in Drug Discovery and Development
Bruce H Morimoto1, Erin Castelloe, Anthony W Fox
1Global Drug Development, Applied Translational Medicine, Celerion, Inc., Lincoln, NE, USA, bhmorimoto@gmail.com.
Handbook of Experimental Pharmacology
|June 21, 2015
Summary
Safety pharmacology is crucial for predicting drug risks before human trials and explaining side effects during development. This field ensures better drug candidate selection for patient safety.
Area of Science:
- Pharmacology
- Drug Development
- Translational Medicine
Background:
- Safety pharmacology is integral to drug discovery and development.
- It predicts clinical risk profiles before first-in-human studies.
- It explores and explains adverse events during clinical development.
Purpose of the Study:
- To introduce safety pharmacology's role in translational medicine.
- To demonstrate translating nonclinical drug properties to clinical consequences.
- To highlight selecting optimal drug candidates for clinical testing.
Main Methods:
- Utilizing safety pharmacology assays, tests, and models.
- Analyzing drug effects on vital signs and laboratory values.
- Employing case studies across all drug development phases.
Main Results:
- Safety pharmacology effectively predicts potential drug risks.
- It aids in refining clinical risk profiles by explaining side effects.
- Case studies illustrate its importance throughout drug development.
Conclusions:
- Safety pharmacology is essential for informed drug candidate selection.
- It bridges nonclinical findings with clinical outcomes.
- Its application enhances patient safety throughout the drug lifecycle.
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