Dermal Toxicity Study in Animal Models
Project Description
We need a quote for a topical GLP study in minipigs. This is to support the pediatric indication so we need the animals of the appropriate age. Following is the summary:
4-Week Dermal Toxicity and Toxicokinetic Study in Minipigs with a 2-Week Recovery 4 groups (control, Low, Medium, High doses), 5 per group/gender Terminal necropsy of 3 animals/sex/group after at least 4 weeks of dosing. Animals designated for recovery necropsy (last 2 animals/sex in Groups 1 and 4, dependent on survival) will undergo at least 2 weeks of recovery following dose administration.
- We will provide BA methods and analytical method for dose prep analysis.
- GLP
- Dermal administration, once daily.
- Normal Clinical Observation/Draize scoring/Body Weight and Food Consumption
- Frequency of TK sampling and number of time points: First and last day; 9 time points.
We will provide a bioanalytical method or we could ship the samples to our current vendor for the analysis. However, our strong preference is to run everything related to the study under one roof.
Project Information
Number:25-00324
Industry:Medical Research
