Assessment of a New Antibiotic involves several key steps to ensure its efficacy, safety, and suitability for clinical use. Here’s a concise overview of the process:
1. In Vitro Testing of Assessment of a New Antibiotic
Microbiological Assays:
Minimum Inhibitory Concentration (MIC): Determine the lowest concentration that inhibits visible growth of target bacteria.
Agar Diffusion Assay: Measure zones of inhibition to assess antibacterial activity.
Spectrum of Activity: Test against a range of bacteria (Gram-positive, Gram-negative, aerobes, anaerobes).
2. In Vivo Testing
Animal Models:
Evaluate efficacy in animal models of infection.
Assess pharmacokinetics (absorption, distribution, metabolism, excretion).
Determine pharmacodynamics (relationship between drug concentration and effect).
3. Safety Assessment:
Toxicology Studies: Conduct acute, subacute, and chronic toxicity tests.
Side Effects: Identify potential adverse reactions.
4. Clinical Trials:
Phase I: Assess safety and dosage in healthy volunteers.
Phase II: Evaluate efficacy and side effects in patients.
Phase III: Confirm efficacy and monitor adverse reactions in a larger population.
Phase IV: Post-marketing surveillance for long-term safety.
5. Regulatory Approval:
Data Submission: Compile and submit all data.
Review and Approval: Obtain approval from regulatory bodies (e.g., FDA, EMA).
Monitoring: Ongoing safety and effectiveness surveillance.