HIV Drug Development—Preclinical Pharmacology and Toxicology Services

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

Support Services

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
  • Carcinogenicity
  • 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.


  • GLP
  • OLAW

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