In the final part of our DART webinar series, we’ll take a look the role of dogs and minipigs in toxicity studies.
The first half of this webinar will focus on the dog’s role in DART studies, according to guidance in ICH S5 (R3). Since dogs share a similar metabolic profile to humans, they’re ideal to study reproductive performance for veterinary products and helpful to determining embryo-fetal developmental (EFD) toxicity. By looking at our own experiences with dogs in reproductive and EFD studies, we’ll discuss the importance of dosage-range studies, special procedures and issues with timed mating, procedures for fetal evaluation, and the limited ability of postnatal behavioral tests.
In the second half, the minipig takes center stage as we examine its role in the safety evaluation of drug candidates, especially for small molecules. Not only do they share metabolic similarities with humans, but they also have many advantages in reproductive physiology, including earlier sexual maturity, a short estrous cycle, and large litter size. However, the litter size and duration of gestation (typically 112-115 days) can be a concern. We’ll share insight into an alternative methodology we’ve developed to address these concerns and how you can incorporate this method into your study design.
There will also be time after the presentation to get your questions answered by our presenters.
Toni Elsom, MSc
Principal Research Scientist
Céline Pique, PharmD, MSc, ERT
Sr Research Scientist, Reproductive & Juvenile Toxicology
Have a scheduling conflict? Sign up even if you can't make it; we'll share the recording after.
View the other webinars in the series:
- ICH S5 - Updates and Implications (October 22)
- The Guidelines and Challenges of Performing NHP DART Studies (October 29)
- Rodents and Rabbits - The Traditional DART Models (November 5)
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