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Summary of Study Offerings


Summary of Study Offerings

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For clients with early stage compounds, we recommend our Early Diagnosis Tests (EDT) to reduce the risks and costs of preclinical safety evaluation by detecting and eliminating potentially toxic drug candidates early. For PCCs or INDs, we provide our clients with tailored GLP toxicology studies for a comprehensive safety assessment.

Early Diagnosis Tests (non-GLP)

  • Mini Ames
  • MNT
  • hERG (patch clamp)
  • QT test
  • 7-day tox

Rate of compound attrition following the EDT model.

tox-edt 2

General Toxicology (non-GLP and GLP)

  • Dose-range finding or MTD
  • Single dose (acute toxicity)
  • Repeat dose (subacute, subchronic and chronic)

Genetic Toxicology (non-GLP and GLP)

  • Ames/mini Ames assay
  • In vitro chromosome aberration assay (CHO-WBL cell and human lymphocyte)
  • In vivo micronucleus assay (rat and mouse)
  • In vitro micronucleus assay (CHO-WBL cell)
  • MLA assay (L5178Y)

A metaphase spread prepared by Giemsa staining (non-banded) showing various types of aberrations (triradial indicated) induced by treatment with 10 μM mitomycin C.

TOX pic only

Safety Pharmacology (non-GLP, GLP)

  • Implanted cardiovascular telemetry (dog, NHP, minipig)
  • Non-invasive DSI JET assessments for biologics (dog, NHP)
  • CNS – functional observation battery (mouse, rat, dog, NHP)
  • Respiration via plethysmography (rat, guinea pig)
  • Respiration via face mask/pneumotach (dog, NHP)
  • hERG assay via manual patch clamp

Developmental and Reproductive Toxicology

  • Dose range finding study on embryo-fetus development (rat, rabbit)
  • Study on fertility and early development to implantation – Seg I (rat)
  • Definitive study on embryo-fetus development with TK – Seg II (rat, rabbit)
  • Peri/Postnatal studies on fetal/neonatal development – Seg III (rat)

Immunotoxicology

  • Tissue Cross Reactivity (dog, NHP, human tissues)
  • Immunogenicity/ADA
  • Immunophenotyping
  • T-cell-dependent antibody responses (TDAR)

Anatomic and Clinical Pathology

  • Toxicological or immunopathology (all species)
  • Clinical pathology, necropsy and histopathology
  • Japanese and Chinese board-certified pathologists
  • Outsource to VPS for studies requesting US board-certification

Routes of Administration

  • Intravenous (bolus, slow bolus, short/long infusion)
  • Oral (gavage, capsule) and nasogastric (NHP)
  • Intramuscular (IM), subcutaneous (SC), intradermal (ID), dermal and intraperitoneal (IP)
  • Others on request (e.g. implant, intraarterial, etc.)

Other Investigations

  • Cardiology – we use VetMed
  • Ophthalmology – in house and board-certified