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. APSL toxicology services were established in 2002 & 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.
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)
- Fertility and reproductive toxicity (Segment 1 study): Rats
- Male fertility study
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)
Pharmacokinetics
- Single/ 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 GLP and Non-GLP Toxicology Studies 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
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Toxicology Studies
Connect with our scientific experts for your drug discovery, development, and manufacturing needs
We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.
Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.
Resources
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Wang-OSO3H catalyzed green synthesis of bioactive isoindolo[2,1- a ]quinazoline-5,11–dione derivatives: An unexpected observation
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The sulphonic acid-functionalized Wang resin (Wang-OSO3H) was explored as a polymeric and recov- erable acidic catalyst for the synthesis of isoindolo[2,1- a ]quinazoline-5,11–dione derivatives under green conditions. Thus the Wang-OSO3H ...
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A novel unprecedented approach for the synthesis of various quinazolinones and dihydroquinazolinones has been using [(n-Bu3Sn)2MO4]n as a catalyst. The reaction has been screened ...
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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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