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Your partner in science for end-to-end CRDMO solutions

Preclinical Toxicology

Jubilant Laboratory is AAALAC-accredited and has been providing pre-clinical toxicology services to many clients across the globe. 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 comprise acute, sub-acute, and sub-chronic toxicokinetic studies in various test systems with different routes of administration, along with in vitro and 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. The team consists of toxicologist certified by Diplomate of the American Board of Toxicology (DABT), European registered toxicologist (ERT) and pathologist by the Indian Board of Toxicologic Pathology (DIBTP).

Pre-clinical Toxicology Services

We provide a comprehensive range of toxicology and safety pharmacology services in accordance with international regulatory guidelines. With routine screening of compounds in the R&D phase, we assist in toxicological safety assessment to identify and eliminate the unsafe elements at the earliest stage in drug development.

Jubilant Biosys has the latest facilities to evaluate the candidate compounds in a professional manner that results in the timely delivery of the reports. The rich experience of our scientific team helps our customers meet their specific preclinical and other early-stage product development needs, enhance their decision-making process, and save time and resources.

Toxicology Services include:

Acute Studies

  • Single dose toxicology studies in rodents (rats/mice)
  • Single extended dose toxicity 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, -ICH Harmonised Tripartite Guideline – S3A: Toxicokinetics, ICH M3 (R2))
  • Sub-chronic Toxicity: 90 days with toxicokinetic studies (OECD 408, ICH Harmonised Tripartite Guideline – S3A, ICH M3 (R2))
  • Standalone Toxicokinetic studies (ICH Harmonised Tripartite Guideline – S3A: Toxicokinetics)

Safety Pharmacology (CNS) In-vivo

  • Modified Irwin test (FOB) in rats/mice
Pre-IND Studies Required for Phase I Trials

  • Acute Toxicity
  • Subchronic Toxicity
  • Genetic Toxicity
  • Safety Pharmacology
  • Toxicokinetics

Different Routes of Administration

  • Oral through gavage
  • Dermal
  • Subcutaneous
  • Intra-peritoneal
  • Intramuscular
  • Intravenous (Bolus and Infusion)

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.