Antiviral drug development is a complex journey from target identification to market approval. It involves rigorous testing, from lab experiments to large-scale human trials, ensuring new treatments are safe and effective against viral infections.
The process combines cutting-edge science with stringent regulatory oversight. Researchers use advanced techniques to discover potential drugs, then carefully evaluate them through preclinical and clinical stages before seeking approval for widespread use.
Antiviral Drug Development Process
Stages of Drug Development
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Frontiers | Strategy, Progress, and Challenges of Drug Repurposing for Efficient Antiviral Discovery View original
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Frontiers | The Signaling Pathways, and Therapeutic Targets of Antiviral Agents: Focusing on the ... View original
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Frontiers | Strategy, Progress, and Challenges of Drug Repurposing for Efficient Antiviral Discovery View original
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Drug development process consists of five main stages
Target identification and validation
Lead compound
Preclinical studies
Regulatory approval and post-market surveillance
Target identification determines specific viral proteins or processes to inhibit viral replication
Lead compound discovery uses methods to identify potential antiviral molecules
High-throughput screening
Repurposing existing drugs
Preclinical studies assess safety and efficacy in cell culture and animal models
Evaluate pharmacokinetics, pharmacodynamics, and toxicity
Clinical trials conducted in three phases to evaluate in humans
Phase I: Safety and tolerability
Phase II: Efficacy and optimal dosing
Phase III: Large-scale efficacy and safety studies
Regulatory approval requires submitting comprehensive data for review
Post-market surveillance monitors long-term safety and effectiveness
Drug Discovery Approaches
Genomic and proteomic approaches identify potential viral targets
Essential viral enzymes (viral polymerases)
Structural proteins (viral capsid proteins)
Host factors required for viral replication (cellular receptors)
Structural biology techniques determine 3D structure of viral proteins
X-ray crystallography
Cryo-electron microscopy
Functional genomics validate importance of targets in viral life cycle