• Study protocol development
• Study management, including:
  • monitoring
  • issue resolution
  • critical data communication
  • draft report reviews

Reproduction Study Management

Mary Moxon and Gill Milburn are RSA toxicologists with a wealth of expertise in the conduct of reproduction studies. Each has more than 30 years experience in the management and reporting of multigeneration studies, one-generation and developmental neurotoxicity studies to regulatory guidelines (OECD 415, 416, 421, 422, 426) and both have conducted a number of bespoke reproduction studies designed to address specific endpoints for the chemical and for the pharmaceutical industries including juvenile toxicity. Mary is also an expert in the conduct of prenatal developmental toxicity studies (OECD 414).

In addition to the expertise in reproduction toxicology, the RSA team has expertise in endocrine disruption, pathology, neurotoxicology, immunotoxicology, metabolism and kinetics. The breadth of this expertise is particularly relevant for the newly adopted test guideline OECD 443, the extended one-generation reproduction study which not only includes assessment of reproductive/developmental endpoints but also the assessment of the potential impact of chemical exposure on the developing nervous and immune systems. This study type may now be required to address data gaps identified through REACH submissions.

The RSA team is extremely well placed to design, monitor and interpret reproduction studies on your behalf. Appropriate summaries and regulatory documents can be prepared and advice given on classification and risk assessments.

See RSA offers independent study management and monitoring services of mammalian toxicity studies