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.

Standards

  • 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
Content last reviewed on November 17, 2017