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Printable Handouts
Navigable Slide Index
- Introduction
- Regulatory status of juvenile toxicology
- Species selection
- Juvenile toxicology species
- Desirable characteristics
- Factors to consider during species selection
- Species comparison
- Dog vs. minipig
- The minipig as an alternative model
- Study design considerations
- Study design questions
- When to dose (1)
- Study designs
- Species-specific technical considerations
- Technical considerations
- Guinea pigs vs. hamsters
- Nonhuman primates vs. rodents
- Practical study design considerations (1)
- Practical study design considerations (2)
- Practical study design considerations (3)
- Cross fostering in rodents
- Standard endpoints
- Routine evaluations
- Dose administration techniques
- When to dose (2)
- Routes of administration - age
- Dosing technique varies for each age
- New routes of administration
- Routes of administration - rabbits
- Exposure and microsampling
- Importance of metabolism/toxicokinetics
- Juvenile studies and exposure assessment
- Ontogeny of metabolic capability
- Metabolism/toxicokinetics
- Microsampling
- Microsampling - toxicology practicalities
- Microsampling - rodent pups
- Microsampling - PND1 rat pup
- Microsampling - juvenile rat study design
- Growth and bone assessments
- Growth and physical development
- Routine assessments of skeletal growth
- Advanced skeleton assessments
- X-rays
- Dual energy X-ray absorptiometry: DXA
- DXA scanning juvenile rabbits (1)
- DXA scanning juvenile rabbits (2)
- pQCT
- Behavioral assessments
- Neurotoxicology - rodents
- Types of neurobehavioral assessments
- Functional observational battery
- Avoidance testing
- Auditory startle response
- Locomotor activity assessments
- Learning and memory assessments
- Social interaction
- Terminal procedures (1)
- Terminal procedures (2)
- Developmental neurotoxicology
- Brain landmarks (1)
- Brain landmarks (2)
- Developmental immunotoxicology
Topics Covered
- Juvenile Toxicology Testing
- Animal Testing
- Animal Models
- Toxicology Study Designs
- Clinical Studies
- Routes of Drug Administration
- Microsampling
- Metabolism
- Toxicokinetics
- Neurobehavioral Assessments
- Developmental Immunotoxicology
Links
Series:
Categories:
Talk Citation
Hoberman, A. and Lewis, E. (2021, May 30). Juvenile toxicity testing [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 6, 2024, from https://doi.org/10.69645/BYBW3408.Export Citation (RIS)
Publication History
Financial Disclosures
- There are no commercial/financial matters to disclose.
- Dr. Elise Lewis has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
A selection of talks on Pharmaceutical Sciences
Transcript
Please wait while the transcript is being prepared...
0:00
Welcome to the module on juvenile toxicity testing prepared by myself,
Alan Hoberman and Elise Lewis both worked for Charles River Laboratories.
I am the Global Director for juvenile toxicology.
I conducted actually one of
the first juvenile toxicity tests in rodents back in the late '70s.
0:21
But it really wasn't until the 2000s that guidance documents from
first the USFDA in 2006 and then Europe in 2008,
in Japan in 2012,
were issued to really look at juvenile toxicology testing.
The regulatory status today involves a harmonized guideline,
the ICHS 11 guideline,
which I have listed here is in progress,
but actually, step four of the progress was issued in
April of 2020 and will become law in various parts of the world over the next year or so.
0:54
First we're going to talk about species selection,
one of the important parts of doing a juvenile toxicology study,
and we use rodents and non-rodents.
1:04
For juvenile toxicology, there are number of
species that can be used and we're going to talk a lot
about why we use one species over
another species when one is appropriate and the other one is not appropriate.
But you can see we use everything from rats,
mice, hamsters, guinea pigs,
dogs, rabbits, non-human primates, and mini-pigs nowadays.
Many times what we're going to select as a species will be what we use in
the general toxicology work with some limitations that we're going to talk about.
1:30
First, let's look at some of the desirable characteristics of rodents and non rodents.
Well, we know the most about rodents.
We use rats most often in our testing.
We know, we understand when estrous cycle good reproductive capacity,
litters gives us large amount of animals to work with.
They grow very quickly.
We can look at the skeletal growth.
We understand a lot about
their immune systems and neuro-behavioral assessments are possible.
Similar things can be done with mice. Non rodents.
We think of the non-human primate,
but we try to avoid using that as much as we can.
Although many of the characteristics are similar to humans,
it's hard to do neuro behavioral screening with them.
Although there's something similar to humans,
many pigs are becoming more and more popular nowadays.
There are several anatomical maturation characteristics
are similar to humans and some things that are different.
Rabbits at times can be appropriate,
dogs can be appropriate at times.
We're going to talk about a lot of that as we go through this module.