Toxicology (Nonclinical/Preclinical)

Our toxicology group is dedicated to assisting clients in developing the appropriate study designs and in using suitable biological models for the safety testing of their compounds. We design and conduct standard preclinical studies to evaluate the safety of new drug candidates, as well as specialty studies with unique lab models to assess efficacy and ensure the quickest, most efficient route to investigational new drug (IND) submission. We have also specialized in developmental and reproductive toxicity (DART) studies for more than 25 years, establishing a reputation for conducting toxicology studies of the highest scientific caliber.

Nonclinical/Preclinical Toxicology

  • General toxicology capabilities
  • GLP-compliant studies
  • Compliance with FDA, ICH, EPA, and OECD guidelines
  • Range-finding, acute, subchronic, and chronic studies
  • Dosing by standard routes, not limited to the following: oral dosing (i.e., gavage, feed, water), dermal, intraperitoneal, subcutaneous, intramuscular, tracheal instillations, and IV bolus or IV continuous infusion, neonatal pup dosing
  • Neurotoxicology studies (adult and developmental)
  • Endocrine disruptor studies
  • Toxicokinetic studies

Support Services

  • Bulk chemical analyses (identity, purity, stability)
  • Dose formulations and analyses
  • On-site surgical services
  • Biological sample analyses (whole blood, plasma, serum, tissues)
  • Vivarium use contracts

Developmental and Reproductive Toxicology (DART)

Testing Services

RTI offers a comprehensive range of DART testing services carried out under good laboratory practices (GLP) for the evaluation of pharmaceutical and chemical products.

  • Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) Segments I, II, and III reproductive/developmental toxicity studies for investigational new drug and new drug application submissions
  • Multigenerational studies to meet Organization for Economic Cooperation and Development (OECD), FDA, or U.S. EPA OPPTS testing guidelines
  • Adult and developmental neurotoxicity
  • Standard and extended OECD 421/422 reproductive/developmental toxicity screens
  • Endocrine studies (including uterotrophic and Hershberger assays, one-generation and in utero/lactational studies, adult male studies, pubertal male and female studies)
  • Validated receptor assays for free and total testosterone, dihydrotestosterone (DHT), androstenedione, estradiol, estrone, progesterone, growth hormone, prolactin, follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid-stimulating hormone (TSH), triiodothryridine (T3), thyroxine (T4), cortisol, corticosterone, aldosterone, adrenocorticotropic hormone (ACTH), and inhibin.
  • Steroidogenesis assay using testis slices

Capabilities

Our service capabilities cover a broad spectrum of assessments.

  • Andrology assessments with automated sperm analysis, using the Hamilton-Thorne Integrated Visual Optical System (IVOS), to determine epididymal and ejaculated sperm number, motility and morphology in all species, and spermatid head counts to calculate daily sperm production (DSP) and DSP efficiency in rodent species
  • Multiple treatment routes
  • Fetal evaluations
  • External examination
  • Fresh tissue dissection for visceral anomalies
  • Double-stained skeletal evaluation for anomalies in both cartilage and bone
  • Neurobehavioral assessments (juvenile and adult), including learning and memory
  • Developmental landmarks
  • Customized longitudinal endocrine studies using cannulation techniques
  • Whole organ cultures or cell culture studies using Sertoli cells, Leydig cells, or granulosa cells

Support Services

  • Custom SAS statistical analyses
  • PK/TK analyses
  • Dose formulation and analysis

More Information

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