Toxicology

Toxicology studies are designed to identify hazards (target organs) and to support risk assessment (determine the likelihood that a toxicity will be a human risk).

Customized toxicology programs

We help clients decide what studies to run, when, and how – and what not to do.

Because all novel drugs are different, Preclinical GPS customizes toxicology study designs for each drug and program. This customization takes into account the following:

  • Modality of your drug (small molecule, antibody, peptide, oligonucleotide, or other).
  • Appropriate species selection.
  • Clinical indication (acute, chronic, oncology, etc.).
  • Patient population (adult, pediatric).
  • Clinical route and dosing regimen, and clinical phase (Phase 1, 2, or 3).
  • Regulatory compliance with GLPs, OECD Guidance, and ICH Guidelines.

Toxicology experience

We routinely run toxicology studies up to 9 months in duration, as well as developmental and reproductive toxicology studies. Depending on program needs, toxicology studies are typically conducted using rats, mice, canines, non-human primates, mini-pigs, rabbits, or other species.

Preclinical GPS has conducted over 800 preclinical studies including 196 GLP studies. Annually, we typically manage over 40 preclinical studies to support 2 to 4 INDs.

Objectives for toxicology programs

Preclinical GPS conducts toxicology studies to identify potential hazards and to develop data for appropriate risk assessments. Hazard identification includes determination of theoretical and real effects of a drug on humans. Risk assessment is the process of determining the likelihood that the hazard is a significant concern to humans.

How We Help

We manage the outsourcing process for these studies using only reputable and experienced laboratories. The outsourcing process includes designing studies, generating requests for proposals, negotiating contracts, implementing studies, monitoring studies, reviewing data and preparing reports. Outsourced studies are supported by our proprietary project management processes to ensure on-time, on budget delivery.

We also author toxicology sections of regulatory documents to support IBs, INDs, NDA, CTA, and BLAs.

We routinely manage the following toxicology studies:

  • General Toxicology in mouse, rat, rabbit, dog, and non-human primates
    • Non-GLP range-finding studies
    • Acute toxicology studies and tolerability studies
    • GLP repeat dose studies
      • 2-week toxicology studies
      • 4-week toxicology studies
      • 3-month, 6-month, and 9-month toxicology studies
    • Tissue cross reactivity as needed
  • Genetic Toxicology
    • Screening and GLP Ames assay
    • Screening and GLP chromosomal aberrations studies
    • GLP in vivo micronucleus studies and other in vivo assessments
  • Developmental and Reproductive toxicology studies in mouse, rat, rabbit and non-human primate
    • Range finding and GLP embryo-fetal development studies (Seg 2)
    • Range finding and GLP fertility studies in males and females (Seg 1)
    • Peri- and postnatal development (Seg 3)