Pharmaceuticals

Hazard Identification: Identifying potential toxic effects of drug substances, including acute toxicity, chronic toxicity, genotoxicity, and carcinogenicity, through preclinical studies (in vitro and in vivo).

Dose-Response Assessment: Establishing the relationship between the dose of a drug and its potential toxic effects, including determining no observed adverse effect levels (NOAELs) and lowest observed adverse effect levels (LOAELs).

Exposure Assessment: Evaluating patient exposure to drugs, considering dosage forms, routes of administration (oral, topical, intravenous), frequency of use, and duration of therapy.

Risk Characterization: Integrating hazard and exposure data to assess the overall risk, including calculating safety margins and assessing whether therapeutic benefits outweigh potential risks.

Toxicological Risk Assessments (TRA): Preparing detailed TRA reports that assess the safety of pharmaceuticals based on toxicology data, including reproductive and developmental toxicity, neurotoxicity, and organ-specific toxicity.

Regulatory Submissions: Supporting regulatory submissions by providing toxicology data and risk assessments for Investigational New Drug (IND), New Drug Application (NDA), and Marketing Authorization Application (MAA) filings.

Evaluation of Impurities: Assessing the toxicological impact of impurities, residual solvents, and degradation products in pharmaceuticals as per ICH guidelines (e.g., ICH M7 for mutagenic impurities).

Occupational Exposure Limit (OEL) Assessment: Establishing safe exposure limits for workers handling pharmaceuticals, including PDE (Permitted Daily Exposure) and acceptable exposure limits for potent drugs.

Post-Market Safety Monitoring: Monitoring adverse event reports and conducting ongoing risk assessments for approved pharmaceuticals based on real-world patient data.

Pharmacovigilance Support: Working with pharmacovigilance teams to assess the toxicological implications of side effects or adverse events reported during post-market surveillance.