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GLP and Non-GLP Toxicology Studies Services

GLP and Non-GLP Toxicology Studies Services

Aurigene offers a full range of exploratory and GLP toxicology studies with a strong regulatory track record over the years.

We offer toxicology studies ranging from single-dose and repeat dose toxicology, genetic toxicology, IND and NDA enabling safety toxicology packages etc. We have successfully filed INDs with the US FDA, MHRA, EMA, DCGI and ANDAs and completed more than 1000 exploratory toxicology studies to support early discovery and candidate selection over a period of 15+ years. Aurigene toxicology services were established in 2002 and GLP certified by Netherlands (2003) and NGCMA – India (2004) CMAs.

In addition to oral, intramuscular, subcutaneous, intradermal, inhalational, intravitreal injection, and intricate intravenous infusion studies, the team handles a variety of other administration routes. We guarantee timely and accurate communication across time zones by streamlining workflows, processes, and communication technologies.

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General Toxicology (Includes Toxicokinetic)

  • Acute toxicity (GLP/Non-GLP): Rats/ mice
  • Exploratory/Dose range finding (MTD): Rats/ mice
  • Sub-acute (14/28 Day), sub-chronic (90 day) and chronic toxicity (6/12 months): Rats/ mice
  • Drug impurity qualification studies: Rats/mice

Reproduction Toxicity Studies (Includes Toxicokinetic)

Genetic Toxicology Studies

  • We routinely conduct IND enabling studies and the following in vitro and in vivo genotoxic studies to support candidate selection
  • Bacterial reverse mutation test (Ames test), both mini Ames and standard Ames
  • In vitro chromosome aberration test in CHO cell lines and human peripheral blood lymphocytes
  • In vitro micronucleus test in CHO cell lines and human peripheral blood lymphocytes
  • Micronucleus test in rodents (Rats/ mice)


  • Single or multiple-dose PK: Rats/ mice and beagle dogs
  • Tissue distribution in rats/ mice using in situ perfusion techniques

Safety Pharmacology Services

  • Cardiovascular - In vitro hERG – Kit based (Non-GLP)
  • CNS - Functional observational battery tests in Rats/ mice

Why Aurigene Pharmaceutical Services?

Experience in submissions to the US FDA and DCGI

Highly qualified and experienced scientists

Capacity to handle more than 1000 rodents at a given time

Excellent infrastructure

Support for standalone to integrated services to IND filings

Comprehensive biology capabilities for Integrated Drug Discovery

GLP certified toxicology lab

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Frequently asked questions

What is a toxicology study?

Toxicology studies help drug discovery scientists understand the adverse effects of New Chemical Entities (NCE) when administered to treat a disease. The studies are done on in vitro assays and in in vivo animal models to know the toxicity profile.

What are GLP toxicology studies?

Good Laboratory Practise (GLP) toxicology studies are conducted under certified regulatory conditions. The studies are carried out based on procedures laid down by OEDC principles.

What is the purpose of toxicology studies/tests?

The purpose of toxicology studies/tests is to know the adverse/harmful effects of New Chemical Entities (NCEs) on the body of the organism on administration. These studies/tests help drug discovery scientists to design drugs.

Why do toxicology tests take so long?

Toxicology tests require a lot of time for chronic toxicity tests (6 to 12 months), other studies such as sub-acute (14 to 28 days), sub-chronic (90 days) require less time when compared to chronic toxicity tests.

What are the laboratory animal species used in in vivo toxicity testing?

Mice, rats, guinea pigs, hamsters, rabbits, dogs, monkeys and minipigs are commonly used in in vivo toxicity testing.


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