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.
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 : 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 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
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Toxicology Studies
Contact Us
Resources
JUNE 28, 2022
Neoantigen Specific T cells For Cancer Immunotherapy
Neoantigen specific T cells for cellular cancer immunotherapy An effective anti-tumor immune response in human is marked by presence of T cells reactive against neoantigens. Neoantigens are HLA-bound unique peptides arise from tumor-specific somatic mutations. Neoantigens are highly immunogenic because they are not present in normal tissues and hence...
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Building successful long-term partnerships with CDMOs from early drug discovery through commercialization
Building successful long-term partnerships with CDMOs from early drug discovery through commercialization Maximizing efficiency in drug research, development, and manufacturing is crucial for turning new innovations into therapeutic and financial benefits. Over the past couple of decades, pharmaceutical companies have increasingly turned to contr...
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Technology meets sustainability - How a complex API development process goes green
We are always looking for ways to enhance the sustainability of our products and services. Our team successfully developed a scalable manufacturing process for the API product of one of our Biotech clients using eco-friendly manufacturing technologies. Read the case study to learn more. ...
Read MoreAlternate end-game strategies towards Nirmatrelvir synthesis: Defining a continuous flow process for the preparation of an anti-COVID drug
2023
Scalable alternate end-game strategies for the synthesis of the anti-COVID drug molecule Nirmatrelvir (1,PF-07321332) have been described. The first involves a direct synthesis of 1 via amidation of the carboxylic acid 7 (suitably activated as a mixed anhydride with either pivaloyl chloride or T3P) with the ...
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Discovery of MAP855, an Efficacious and Selective MEK1/2 Inhibitor with an ATP-Competitive Mode of Action.
2021
Mutations in MEK1/2 have been described as a resistance mechanism to BRAF/MEK inhibitor treatment. We report the discovery of a novel ATP-competitive MEK1/2 inhibitor with efficacy in wildtype (WT) and mutant MEK12 models. Starting from a HTS hit, we obtained selective, cellularly active ...
Read More -
Synthesis of Anti-covid Drug Nirmatrelvir Using Flow Chemistry
2021
Synthesis of the anti-covid therapeutic Nirmatrelvir by using flow chemistry to enhance efficiency of amide to nitrile conversion in a functionally and Stereochemically Embellished environment. ...
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Simple and efficient synthesis of imidazoquinoxalines and spiroquinoxalinones via pictect-spengler reaction using Wang resin, Synthetic Communications
2021
An efficient approach for the synthesis of various imidazoquinoxalines and spiroquinoxalinones has been reported from 2-(1H-imidazol-1-yl) aniline and .. ...
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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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