Pharmaceutical Toxicology Services by ToxHub

Non-Clinical Services:

At ToxHub, we offer a broad range of non-clinical services to support pharmaceutical development: 

• De-risking of drug candidates during early discovery phases through custom-made toxicology strategies, including design, timelines, and evaluation of results for in silico (QSAR), in vitro, and in vivo investigational non-GLP studies. 

• Toxicity and Safety Pharmacology study identification, protocol design, laboratory proposal management, and assistance with laboratory selection, including site visits. 

• On-site study monitoring, data interpretation, and study report reviews for both GLP and non-GLP studies. 

• Investigation of Mode of Action and human relevance concerning toxicological effects. 

• Non-clinical services for Paediatric Investigation Plans (PIP) according to European Regulation (EC) No 1901/2006, including juvenile study protocol design and excipient analysis for specific paediatric formulations. 

• Non-clinical local tolerance evaluations to support human exposure to drug products (active substances and excipients) at contact sites, following the EMA Guideline (EMA/CHMP/SWP/2145/2000 Rev. 1). 

Pharma Risk Assessment Services

At ToxHub, we provide specialized risk assessment services to ensure the safety and compliance of your pharmaceutical products: 

• Excipient safety assessment, including exposure scenarios, Margin of Safety (MoS) calculations, including proposal for adjusting administration dosages, and evaluation of site-of-contact reactions. 

• Risk assessment and qualification strategies for process impurities and other contaminants, such as Nitrosamines. 

• Extractables & Leachables (E&L) risk assessment, ensuring product safety and regulatory compliance. 

• In silico assessment (QSAR modelling, analogue identifications and read across justification) of toxicological endpoints for data-poor substances, as per ICHM7. 

PDE and OEL Services

At ToxHub, we offer expert services for the derivation of safety exposure limits: 

• Permitted Daily Exposure (PDE) levels to address cross-contamination in shared facilities for active pharmaceutical ingredients (API) and isolated pharmaceutical intermediates (IPI). 

• Occupational Exposure Limits (OEL/OEB) for active pharmaceutical ingredients (API) and isolated pharmaceutical intermediates (IPI) in the work environment. 

• PDE and OEL assessments for shared facilities of veterinary products, according to VICH GL18. 

• Application of Read-Across and Grouping approaches for data-poor chemicals for the purpose of filling the data gaps, in accordance with ECHA guidelines. 

Environmental Risk Assessment (ERA)

At ToxHub, we conduct Environmental Risk Assessments (ERA) for human medicine in compliance with the latest EMA guidance (EMEA/CHMP/SWP/4447/00 Rev. 1 – Corr.), and for veterinary medicines, according to VICH GL6 e VICH GL38. This includes: 

• Comprehensive literature search using public and commercial databases; 

• Estimation of environmental exposure; Persistence, Bioaccumulation and Toxicity (PBT); calculation of the initial Predicted Exposure Concentration (PEC); 

• Evaluation and Testing Strategy for Endocrine Disruptors (ED); 

• Application of Read-Across and Grouping approaches for data-poor chemicals for the purpose of filling the data gaps, in accordance with ECHA guidelines.