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Jubilant Biosys

Delivering the Added Dimension in Drug Discovery Services

Toxicology Studies

Jubilant Biosys offers a large array of GLP and non-GLP preclinical toxicology studies to its customers. The studies, in which our toxicology services team has expertise (certified toxicologist by American Board of Toxicology, DABT and pathologist by Indian Board of Toxicologic Pathology, DIBTP), comprise of acute, sub-acute, sub-chronic studies in various test systems with different routes of administration, along with in-vitro/in-vivo genotoxicity studies. These studies are performed in compliance with global regulatory guidelines, ICH, OECD, etc. at Jubilant’s GLP certified toxicology lab in India.

Toxicology Services

Acute Studies

  • Single dose toxicology studies in rodents (rats/mice)
  • Single dose toxicology studies in non-rodents (rabbits)

Repeated Dose Toxicity Studies in Rodents (rats/mice/guinea pigs) and Non-Rodents (rabbits)

  • Sub-acute Toxicity: 14 days DRF and 28 days with toxicokinetic studies (OECD 407)
  • Sub-chronic Toxicity: 90 days with toxicokinetic studies (OECD 408)
  • Standalone Toxicokinetic studies (OECD 417)

Safety Pharmacology (CNS) In-vivo

  • Modified Irwin test (FOB) in rats/mice

Different Routes of Administration

  • Oral through gavage
  • Dermal
  • Subcutaneous
  • Intra-peritoneal
  • Intramuscular
  • Intravenous

Genetic Toxicology Study Services

In-vitro Toxicology Services

  • Bacterial Reverse Mutation Test (Ames Test) using Salmonella Typhimurium and E.coli WP2 uvrA
  • In-vitro Mammalian Chromosome Aberration Test using Human Peripheral Blood Lymphocytes
  • In-vitro micronucleus test using Human Peripheral Blood Lymphocytes

In-vivo Toxicology Services

  • In-vivo Mammalian Erythrocyte Micronucleus Test in Mice/Rat (with and without Toxicokinetic)
  • In-vivo Mammalian Bone Marrow Chromosome Aberration Test in Mice/Rat (with and without Toxicokinetic)

Pathology Services

We offer Stand Alone Pathology Services (tissue processing through slide evaluation and reporting) for the in-life phase of toxicology and efficacy studies conducted elsewhere.