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
Other Services
- Carcinogenicity Studies and Services
- DMPK Studies
- General Toxicology Services
- Genetic Toxicology Studies and Services
- In vitro Biology and Assay Services
Carcinogenicity Studies and Services
DMPK Studies
General Toxicology Services
Genetic Toxicology Studies and Services
In vitro Biology and Assay Services
In vitro Genotoxicity Testing Services
In vivo Pharmacology Studies and Services
Male Fertility Study and Services
Microbiology Testing Services
Safety Pharmacology Studies and Services
Virtual Tour
Hyderabad R and D Center
Bangalore R and D Center
Toxicology Studies
Resources
Neoantigen Specific T cells For 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 bypass central thymic tolerance. The success of immune checkpoint blockade...
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Accelerating Drug Discovery Through Innovative Partnerships
Genomics plays a vital role in identifying which gene is associated with a specific disease. A gene called CNOT1 is for example known for it's effect on brain development and for impairing memory and learning. Despite the great promise genomics provides in understanding the disease, genes are not the best drug targets....
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Systematic formulation design - shorten development cost & time
Project Challenge: Existing formulation (lower strength - 50 mg) was manufactured using direct compression process. This formulation posed poor powder flow and content uniformity issues during scale-up. Development of new strength 150 mg without any process issues was a challenge. Solution design: Preliminary pre-formulation, stress study and PSD impact assessmen...
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An efficient and convenient protocol for the synthesis of tetracyclic isoindolo[1,2-a]quinazoline derivatives
2016
A convenient and one-pot synthesis of tetracyclic isoindolo [1,2-a]quinazoline derivatives via Lewis acid mediated sequential C–N bond formation reactions is reported. This protocol provides a simple and rapid strategy for the synthesis of 12-benzylidene-10,12-dihydroisoindolo[1,2-b]quinazoline derivatives. However, a variety of tetracyclo indole fused quinazol...
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A simple RP-HPLC method development and verification of the Dissolution of Bromelain-A Complex mixture of proteolytic enzymes, in delayed release tablets
2005
Bromelain is a complex natural mixture of proteolytic enzymes derived from pineapple (Ananas cosmosus), which has good therapeutic properties. Bromelain can be found in all tissues of pineapple plants, including the stem, fruit, and leaves. Bromelain plays an important role in the treatment of many diseases such as soft tissue inflammation and edema, deep derma, ...
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A sensitive and a simple RP-HPLC method development and verification for the quantitative estimation of Cholecalciferol in tablets
2005
Cholecalciferol, also known as Vitamin D3, is widely prescribed for the treatment osteomalacia and osteoporosis [1]. It also plays a key role in calcium and phosphorus homeostasis and skeletal mineralization [2]. IUPAC name of Cholecalciferol is (3β, 5Z, 7E) 9,10-secocholesta-5,7,10(19)-trien-3-ol, whose molecular weight is 384.64 g/mol and its molecular formula...
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A simple RP-HPLC method development and verification for the quantitative estimation of Sodium Butyrate in tablets
2005
Sodium butyrate is the sodium salt of butyric acid (Fig. 1), which exhibits various properties such as immune system modulator, antioxidant, and anti-inflammatory properties [1]. Furthermore, sodium butyrate is used as a promoter of growth in milk replacer formula for young calves [2]....
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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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