TOXICOLOGY SERVICES

What is Toxicology?

The process of development of new healthcare products is designed to ensure that the innovative products are effective, safe and available to the patients in a shortest possible time. Safety evaluation of New healthcare products is identifying its potential to exert a harmful effect on human, animal or environment. These safety tests provide crucial information for planning human trials and are required by law to be tested on animals and other test systems. We conduct of bothDiscovery (Non-GLP)and GLP toxicity studies required by Pharmaceutical, Biotech and Biopharma, Agrochemical and Medical Device Companies for their regulatory submissions.

General Toxicity Studies

1. Single dose toxicity studies in rats and mice
2. Maximum Tolerated Dose (MTD) in rats and mice
3. 7-day repeated dose toxicity study with or without Toxicokinetics in rats and mice
4. 14-dayto 28-day repeated dose toxicity study with or without Toxicokinetics in rats and mice

Genetic Toxicity Studies

1. Reverse Mutation Assay (Ames Assay)
a. Mini Ames – Using 2 or 3 strains of Salmonella Typhimurium
b. Full Ames- Using all 5 strains of Salmonella Typhimurium

2. Micronucleus Test (MNT)
a. In-Vivo Mammalian Erythrocyte Micronucleus Test in Mice

3. Chromosomal Aberration Assay
a. In-Vitro Mammalian Chromosome Aberration Test
b. In-Vivo Mammalian Bone Marrow Chromosome Aberration Test in Mice.

Discovery Toxicity Studies

Toxicity is not only a safety concern but also a major cause of compound attrition during drug development. Accurately predicting which molecules are safe and less likely to encounter development hurdles can both save investment and improve productivity.

We offer following discovery toxicity services in combination with DMPK and Other GLP toxicity testing;

1. Single dose toxicity studies in rats and mice
2. Maximum Tolerated Dose (MTD) in rats and mice
3. 7-day repeated dose toxicity study with or without Toxicokinetics in rats and mice
4. 14-day to 28-day repeated dose toxicity study with or without Toxicokinetics in rats and mice
5. Genetic Toxicity Studies – Mini Ames, In Vivo Micronucleus test
6. Non-GLP reproductive toxicity studies

GLP Toxicity Studies

1. Acute toxicity Studies
a. Single-Dose Toxicity Study in Rodent Models by various routes
b. Acute Eye Irritation study in rabbits
c. Acute Dermal Toxicity study in Rats or rabbits
d. Acute Skin sensitization study in Rabbits
e. Guinea Pig Maximization study
f. Acute Systemic toxicity study in mice.

3. Developmental & Reproductive Toxicology
a. Embryo Foetal Development Study in Rodent and RabbitsModels—DRF and Definitive
b. Male and Female Fertility Study in Rodents
c. One and Two Generation Reproductive Toxicity studies

2. Repeated Dose toxicity Studies
a. 7-14-Day Repeat Dose Toxicity Study in Rodents
b. 28-Day Repeat Dose Toxicity Study in Rodents and Non-Rodents
c. 90-Day Repeat Dose Toxicity Study in Rodents and Non-Rodents
d. 180-Day Chronic Toxicity Study in Rodents and Non-Rodents
e. Carcinogenicity study in Rodents

4. Genetic Toxicity Studies
a. Reverse Mutation Assay (Ames Assay) Full Ames- Using all 5 strains of Salmonella Typhimurium
b. Micronucleus Test (MNT) In-Vivo Mammalian Erythrocyte Micronucleus Test in Mice
c. Chromosomal Aberration Assay In-Vitro Mammalian Chromosome Aberration Test Human Lymphocyte Assay

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