Protecting the future – the importance of reproductive and juvenile tox studies

Envigo will be hosting the next free lunch and learn event with a focus on reproductive and juvenile toxicology. Dr. Robert Parker, Director of Developmental and Reproductive Toxicology, and Elizabeth Baxter, Sr. Toxicologist, will be providing guidance on how to optimize your programs and niche studies in juvenile or neonate animals.

Your toxicology data provides you guidance of the adverse effects on an adult population but how early do you start to consider the effects on a pediatric population or the effect on the next generation?

  • How do you design reproductive studies to be specific to your drug candidate?
  • Have you considered “enhanced" studies that will allow you to commence studies in women of child-bearing potential earlier?
  • Why and when do you need to conduct juvenile tox studies?
  • What are the Agency requirements (e.g. two species, age of animals, formulation consistency)?
  • What are my responsibilities as a Sponsor-organization for the Pediatric Investigation Plan (PIP) 

Join Envigo and industry speakers at this free event and learn about what options you have for conducting your repro and juvenile studies.