Toxicological Services
Intrinsik’s experienced team include board certified toxicologists to provide expert assessments and advice.
Services:
Impurities, and Extractables and Leachables Toxicological Risk Assessments
- Surrogate Justification and Selection for Extractable & Leachable Compounds Lacking Toxicity Data
- Evaluation of Extractable & Leachable Toxicity at Functional Group Level
- Evaluation of impurities in the API and/or drug product consistent with ICH M7 recommended approaches for initial assessment of impurities, using an FDA-validated software program that includes both expert rule- and statistical-based models
- Identification of structural alerts in pharmaceutical compounds and impurities using QSAR
- Evaluation of extractable/leachable impurities and justification for the safety of extractables in the API and drug product
- Support for Toxicity Testing of Impurities
- Impurity Purge Evaluation
Excipients
- Evaluation of excipients that exceed FDA inactive ingredient levels and development of higher safe levels acceptable to the agency
- Excipient Qualification Involving Permissible Daily Exposure (PDE), Tolerable Intake (TI), Acceptable Intake (AI), and Threshold of Toxicological Concern (TTC) Derivations
- Specification Limit and Toxicological Justification
Nitrosamine and Nitrosamine Drug Substance Related Impurities (NDSRIs)
- Nitrosamine Risk Assessment
- Assistance with Carcinogenic Potency Categorization Approach (CPCA) for NDSRIs
- Alternative AI Derivation for NDSRIs using Robust Surrogate Data
- QSAR Support for Alternate NDSRI Surrogate Selection
- Support for Nitrosamine-Specific In Vitro and In Vivo Genotoxicity Testing
Pharmaceutical Environmental Health and Safety
- Occupational Health Characterization (OHC), Occupational Exposure Limit (OEL) Derivation and Occupational Exposure Banding (OEB)
- Manufacturing Cleaning Validation
- Childproof Packaging F-value Calculation
- Safety Data Sheets
- Ecological Risk Assessment
