Safety and Toxicology Studies

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CNS Safety

  • Tail suspension test in mice
  • Spontaneous locomotor activity measurement in rats
  • Rotorod testing in rats and mice

Genotoxicity Studies

  • Mini Ames/Complete Ames
  • Mouse Lymphoma Assay
  • Chromosomal Aberration
  • Micronucleus Test

Exploratory Toxicity studies

  • Acute toxicity/maximum tolerated dose (MTD)
  • Repeat dose 7-90 Days Toxicity studies
  • Toxicokinetic studies (TK)
  • Histopathology (with a partner)

Expertise of GVK BIO in Toxicology Studies

Choosing a lead compound from the pool of candidates does not need to be so time consuming or costly.  Whether you are in the exploratory candidate selection stage in pharmaceuticals or agrochemicals, efficient use of exploratory testing services can be your simple answer to a challenging decision. GVK BIO’s scientific team has extensive experience conducting toxicology evaluation studies, using enzymatic assays and immunoassays to support kidney, cardiac, and muscle injury in a variety of matrices, including serum, plasma, and urine. At GVK BIO, our experienced and skilled teams have access to the latest technology that can make a difference to our clients by designing time- and cost-effective strategies for early toxicology assessment of a compound or compound series. In fact, half of our scientists have over 10 years of experience performing non-GLP toxicology studies.

The risk assessment done using toxicology evaluation studies is vital to characterize potential adverse effects that may occur, and to estimate a safe starting dose and dosage regimen as guidance for steps in Drug Discovery.  GVK BIO will conduct both standard and customized toxicology studies to meet your safety assessment needs as well as your regulatory requirements.

These programs are typically intended to identify the toxicological mode of action (MOA)/adverse outcome pathway (AOP) affected by the compound in question.  We establish custom in vitro and in vivo models to answer specific toxicological questions.

We also offer exploratory and discovery toxicology services to characterize potential (for example on-target) or observed toxicity issues.  Through an understanding of mechanistic toxicology at the early research stage, we can generate information that informs molecule design, candidate selection and translational risk assessment.

If required we can build and deploy novel in vitro mechanistic assays for screening of candidate compounds to provide comparative data on toxicological risk. This data can be used to drive further chemistry. Our experience in this area spans the agrochemical, chemical, consumer products and pharmaceutical industries.

At GVK BIO, we are here to collaborate with you and guide you through the most appropriate studies and study designs so that you can make informed decisions quickly and at reduced cost. We have experts in all necessary disciplines including regulatory affairs, and our experienced program managers offer you proactive guidance and dedicated responsiveness to support your candidate comparison program.

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