This service can be used to provide pharmacokinetic and safety assessments of products in mice, rats, rabbits, dogs, and nonhuman primates.
Main Areas of Focus
- To fill specific gaps in an investigator’s drug development plan as they advance their product toward clinical investigation
- To help investigators obtain data to get additional funding
- To help with prospective partnerships
- To help getting regulatory permission to continue
The following types of studies can be conducted:
- Quantitation of drug and metabolite levels in plasma
- Determination of bioavailability and other pharmacokinetic parameters
- Evaluation of products as substrates, inhibitors, or inducers of cytochrome P450 enzymes
- In vitro genetic toxicity assessments (e.g., Ames test)
- Determination of No Observed Adverse Effect Level (NOAEL) and maximum tolerated dose (MTD)
- Determination of systemic and specific target-organ toxicity following single or multiple administrations of product
- Local tolerability and/or irritability assessments
- Safety pharmacology (CNS, cardiovascular, respiratory)
- Reproductive toxicity
- Biodistribution and integration of nucleic acid-based products
- Tissue cross-reactivity and immunogenicity of biological products
- Toxicogenetics, proteomics, and/or metabolomics
- New toxicology model and new test system development (e.g., mitochondrial toxicity screening, safety biomarkers)
- Studies can be conducted under GLP guidelines
Investigators seeking these services receive no funding from NIAID, but instead receive products or information generated by NIAID-funded contractors on their behalf.
Who Can Use This Resource
- Product must be defined and of known chemical structure.
- Investigator must have preliminary data to support the continued development of product.
- NIAID does NOT offer the primary screening of previously untested products via these services.
How To Get Started
- Follow the procedures for requesting access to NIAID contract services.
- In addition, data packages for Animal Pharmacology and Toxicology Services should address the following items:
- Composition of any formulated product proposed for study
- Availability of API reference standard
- Analytical assays available for quantitation of API in formulations and animal plasma or tissues
- Proposed clinical trial design for later-stage IND-enabling studies