General Toxicology Testing
Toxicology services towards Drug development
Vipragen places a significant emphasis on safety screening as a fundamental requirement in the preclinical evaluation of drug candidates. With expertise in Repeat Dose toxicity studies and Reproductive Toxicology studies, Vipragen has conducted a multitude of toxicity testing studies involving various groups and multiple routes of administration. This dedication to comprehensive safety assessments is essential for ensuring the safety and well-being of individuals and the success of drug development endeavours. Vipragen's proficiency in toxicology services in India and across the world plays a pivotal role in identifying and mitigating potential risks associated with drug candidates, facilitating informed decisions in the drug development process.
General Toxicology Services in India
Single Dose/Acute/MTD/6 Pack Toxicology Services in India
Vipragen conducts Single Dose/MTD/6 Pack Studies to evaluate acute systemic toxicity, skin and eye irritation, corrosion, and skin sensitization, crucial for assessing drug safety and suitability for further development, ensuring human health protection and pharmaceutical research success which includes:
- » Single Dose and MTD Range Finding Studies – Rat and Mice (OECD 423/425)
- » Single Dose Dermal Toxicity Study in Rat (OECD 402)
- » Single Dose Dermal Toxicity Study in Rabbit (OECD 402)
- » Acute Inhalation Toxicity Study in Rat (OECD 403)
- » Single Dose Oral Toxicity Study in Rat (OECD 423)
- » Dermal Irritation/Corrosion Study in Rabbit (OECD 404)
- » Ocular Irritation Study in Rabbit (OECD 405)
- » Skin Sensitization Study – Guinea pig (OECD 406)
Repeated Dose Toxicity (Subacute, Subchronic and Chronic) services in India
Vipragen offers a comprehensive suite of Repeated Dose Toxicity studies in India that adhere to international guidelines and include an extensive range of assessments, as follows:
14-Day Repeated Dose Toxicity Study in Rat and Mice:
A study designed to evaluate the effects of a compound administered daily for 14 days, which may or may not include toxicokinetic (TK) assessments.
28-Day Repeated Dose Toxicity Study in Rat and Mice with or without Recovery and TK (OECD 407, ICH M3 R2):
An extended version of the 14-day study, this evaluation spans 28 days and can include recovery periods and TK assessments.
90-Day Repeated Dose Toxicity Study in Rat and Mice with or without Recovery and TK (OECD 408, ICH M3 R2):
This study provides a longer-duration assessment of the compound's effects over 90 days, with the option for recovery periods and TK evaluations.
Chronic Toxicity (6-12 Months) in Rat and Mice (OECD 452, ICH M3 R2):
Designed for more extended evaluations spanning 6-12 months, this study assesses the chronic effects of the compound.
Combined Chronic Toxicity/Carcinogenicity Study in Rat and Mice (OECD 453):
A study that evaluates both the chronic toxicity and potential carcinogenicity of the compound, adhering to OECD guidelines.
Carcinogenicity Study in Rat and Mice (OECD 451, ICH M3 R2):
A dedicated study focused on assessing the potential carcinogenic effects of the compound in rodents. These Repeated Dose Toxicity studies are critical for understanding the compound's safety profile, potential long-term effects, and its suitability for further development.
Vipragen's expertise in conducting a range of repeated toxicity studies and providing comprehensive evaluations ensures that pharmaceutical research and development efforts are well-informed and safety-oriented.