Final answer:
To conduct a SQRA for a drug's suitability for human use, identify hazards, estimate risks using a scoring system, consider control measures, evaluate overall risk, and make decisions based on acceptable risk thresholds.
Step-by-step explanation:
To conduct a semi-quantitative risk assessment (SQRA) and determine whether a drug is suitable for administration to humans, it involves evaluating the potential risks associated with the drug against predetermined criteria. The process generally consists of several key steps:
- Identify Hazards: Determine what potential adverse effects the drug could cause.
- Estimate Risks: Assess the probability and severity of the hazards occurring, often using a scoring system to quantify these factors.
- Control Measures: Identify what measures are in place to minimize these risks, and assess their effectiveness.
- Risk Evaluation: Based on the scores given to the probability and severity, and the effectiveness of the control measures, calculate an overall risk rating.
- Decision Making: Use risk evaluation results to make decisions regarding the drug's suitability for human administration, considering the acceptable risk assessment threshold defined by regulatory agencies.
This assessment must be done comprehensively and systematically to ensure that all potential risks are considered and appropriately managed.