Toxicology
JSW Life Sciences offers the complete range of short, medium and long-term toxicology studies necessary to get a compound approved in order to enter clinical trials.
Furthermore, according to EMEA and FDA recommendations, we are able to perform biomarker profilings based on rat or human samples that will provide substantial predictive safety information.
Toxicology
We offer to perform all toxicological studies in animal models that are to be performed according to guidelines issued from international institutions and regulatory agencies (EMEA, FDA, OECD…).
JSW Life Sciences is especially aware of the importance to perform development programs in the shorted time possible to reduce costs. JSW Life Sciences' expertise in safety questions as well as in related issues like biodistribution, pharmacokinetics, stability, bioanalytical sampling analysis, in vitro metabolism screening and many more will speed up your program and thereby reduce costs.
Regarding gene therapy products we have special experience in toxicology and safety as well as biodistribution and efficacy investigations.
Biomarker profiling
The Predictive Safety Testing Consortium (PSTC) is a unique public-private partnership, that brings together pharmaceutical companies to share and validate each other’s safety testing methods under advisement of the FDA and its European counterpart, the EMEA.
In May 2008, the FDA and EMEA confirmed their joint review and acceptance of new laboratory tests on urine which signal kidney injury. The FDA and EMEA jointly came to the conclusion that:
- the kidney biomarkers are acceptable in the context of non-clinical drug development for the detection of acute drug-induced kidney toxicity;
- the kidney biomarkers provide additional and complementary information to the currently available standards;
- the use of kidney biomarkers in clinical trials is to be considered on a case-by-case basis in order to gather further data to qualify their usefulness in monitoring drug-induced kidney toxicity in man.
The newly accepted biomarkers are KIM-1, Albumin, Total Protein, b2-Microglobulin, Cystatin C, Clusterin and Trefoil factor-3. The use of these new tests can now be used in laboratory research to predict the safety of experimental drugs, allowing drugs to reach market faster and with greater confidence in their safety. The PSTC is actively involved in research to further qualify the biomarkers for use in clinical drug development.