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.
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
Support for standalone to integrated services to IND filings
Comprehensive biology capabilities for Integrated Drug Discovery
GLP certified toxicology lab
JUNE 28, 2022
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...Read More
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....Read More
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...Read More
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...Read More
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 ...Read More
Cholecalciferol, also known as Vitamin D3, is widely prescribed for the treatment osteomalacia and osteoporosis . It also plays a key role in calcium and phosphorus homeostasis and skeletal mineralization . 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 formul...Read More
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
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.
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.
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.
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.
Mice, rats, guinea pigs, hamsters, rabbits, dogs, monkeys and minipigs are commonly used in in vivo toxicity testing.
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