Toxicology IND Preclinical Research Services by Altogen Labs CRO

Altogen Labs, a preclinical CRO, provides essential safety and efficacy testing for novel medicines (GLP-compliant pharm/tox assays per FDA IND requirements). Company works with renowned academic research organizations and pharma/biotech industry to reduce GLP studies timelines and costs while maintaining high quality and GLP standards. Altogen Labs preclinical CRO services includes efficacy xenograft studies (over 100 validated xenografts), assay development (ELISA, in vivo RNAi, biodistribution, etc) and full spectrum of pharm/tox safety assays.

Pharmacology and toxicology testing performed both in vitro and in vivo, ensuring safety and effectiveness that is of utmost importance for any novel medical test compound. Toxicology studies are essential in determining safe dosage amounts, as well as understanding mechanism of action and ways of drug delivery for humans. Standard toxicology tests to assess toxicology profile of the novel medical compound include: acute toxicity (short-term toxicological effects), sub-chronic toxicity (repeated administration of small doses of the test compound), and chronic toxicology (adverse effects following repeated exposure for long period of time). Pharmacology PK/PD tests performed to supplement safety data with pharmacokinetics, dynamics, and metabolism analysis.

While novel test compound efficiency and safety testing can be standard, Altogen Labs offers a number of custom preclinical services to understand the mechanism of action of test compound. These assays include the biomarker screening, gene expression analysis (both protein and mRNA expression levels), gene silencing functional assays (RNAi library screening), correlation of PK/PD assays with tissue biodistribution and hematological analysis to predict and identify possible adverse effects in humans. Altogen Labs perform all in vivo laboratory services under IACUC regulated guidelines and committed to the highest standards of laboratory animal welfare. The variety of oncology, pharmacology, and biotechnology services provided by Altogen Labs are all executed timely, with high quality, and at highly competitive prices to ensure the success of the project and guarantee that client expectations are met.