Drug Safety Studies

A key component of the Investigational New Drug (IND) application in preclinical drug development is the safety study, which gathers preliminary efficacy, toxicity, and pharmacokinetic data, and establishes the initial dosing range for first-in-human Phase I clinical trials.

What are drug safety studies?

Drug safety studies may include pharmacokinetics, acute toxicity, repeat dose toxicity, genotoxicity, carcinogenesis, tumorigenicity, and developmental and reproductive toxicology testing

Testing Capabilities

  • Study design
  • Dose route determination
  • Clinical pathology evaluation
  • Necropsy
  • Histology
  • Pathology / histopathology

Testing Categories

Pharmacokinetic Studies

  • Single Dose Pharmacokinetic Study in Rodent Models
  • Single Dose Pharmacokinetic Study in Non-Naïve Canine Models — Parallel Session
  • Single Dose Pharmacokinetic Study in Non-Naïve Canine Models — Crossover Sessions
  • Repeat Dose Pharmacokinetic Study in Non-Naïve Canine Models
  • Single Dose Pharmacokinetic Study in Non-Human Primates
  •  Repeat Dose Pharmacokinetic Study in Non-Human Primates

Acute Toxicity—Sample Designs

  • Single-Dose Toxicity Study in Rodent Models, Canine Models, and Non-Human Primates
  • MTD Determination with Repeat Dose Range-Finding in Rodent Models and Non-Rodent Models (Canine, Swine, and Non-Human Primates)

Repeat Dose Toxicity Studies—GLP

  • 7-14-Day Repeat Dose Toxicity Study in Rodent Models, Canine Models, and Non-Human Primates
  • 28-Day Repeat Dose Toxicity Study in Rodent Models, Canine Models, and Non-Human Primates
  •  90-Day Repeat Dose Toxicity Study in Rodent Models
  • 90-Day Repeat Dose Toxicity Study in Non-Rodent Models
  • 6-Months Chronic Toxicity Study in Rodent Models
  • 9-Months Chronic Toxicity Study in Non-Rodent Models
  • Carcinogenicity in Rat and Mouse (2 Year Duration) and Transgenic Mice (6 Month Duration) Models

Genotoxicity Studies

  • Ames Reverse Mutation Assay in S. typhimurium and E.coli
  • Chromosomal Aberration Assay with CHO cells
  •  Chromosomal Aberration Assay with Human Lymphocytes
  • Rodent Bone Marrow Micronucleus Test
  • Dose-Verification Study
  • COMET Assay

Developmental & Reproductive Toxicology

  • Embryo Fetal Development Study in Rodent Models—Dose Range Finding
  • Embryo Fetal Development Study in Rodent Models—Definitive
  • Embryo Fetal Development Study in Rabbits—Dose Range Finding
  • Embryo Fetal Development Study in Rabbits—Definitive

Toxikon’s Expertise in Drug Safety Studies

With an industry-leading foundation in toxicology, analytical chemistry, microbiology, and biocompatibility, Toxikon is well-positioned to support your IND / NDA / BLA applications by providing the full range of drug safety testing. Toxikon holds extensive certifications and licenses to meet international regulatory requirements for data quality, acceptability, and harmonization. Choose a preclinical contract research organization you can trust to help you win regulatory approval for your pharmaceutical products