Study programs tailored to regulatory requirements
Labcorp has been working with global regulators and scientific bodies on ED testing for many years. From the outset it is important to understand the science and regulation relevant to your substance, to optimize its regulatory journey. Our study directors and regulatory experts combine their expert insight and knowledge to advise on the optimum approach. That may mean leveraging existing data and QSARs to make weight of evidence arguments or it may require a new study program for your substance. Our dedicated technical team ensure any studies run efficiently and to the necessary standards, and our analytical chemists deliver verifiably results. This is then wrapped into a final dossier with our team supporting your final submission. Beyond submission, our regulatory team can support you by engaging with regulators to advocate for your substance.
Find out more about our ED regulatory consultancy service by clicking here.
Conceptual level 1 testing capabilities
QSAR modelling and read-across form a vital part of weight of evidence arguments for endocrine disruptor endpoints. They also signal appropriate in vitro and in vivo testing strategies. Data-driven insights are key to the successful use of QSAR model predictions. You can rely on our expertise and experience in leveraging model predictions in your submissions. Find out more about our in silico capabilities here.
Expertise in conceptual level 2 ED testing
A suite of in vitro assays suitable for Level 2 ED testing are available in house:
- OECD 455 Estrogen Receptor Transcriptional Activation (ERTA)
- OECD 456 H295R Steroidogenesis
- OECD 458 Androgen Receptor Transcriptional Activation (ARTA - AR Calux®)
- OPPTS 890.1200 Aromatase Assay
Expertise in conceptual level 3 ED testing
Routine level 3 in vivo ED tests available are:
- OECD 440: Uterotrophic assay
- OECD 441: Hershberger assay
- OECD 229: Fish Short Term Reproduction Assay (FSTRA)
- OECD 230: 21-Day Fish Assay
- OECD 231: Amphibian Metamorphosis Assay (AMA)