Strategies for Reducing the Number of Animals in Toxicity Testing: A Comparative Approach for Rodent and Large Animal Studies
Gene Therapy Utilizing Adeno-Associated Viral (AAV) Vectors: Historical Data Review to Characterize Common Challenges and Identify Opportunities for Refinement
Comparison of Toxicology Assessment Baseline Data Collected Using Two Restraint Methods in Nonhuman Primates: Restraint Chair/Pole and Collar vs. Procedure Cage
Downsized Sinclair™ vs. Göttingen™ Minipigs Similarities and Differences of Toxicological Reference Range Data in Preclinical Safety Studies
Ocular Imaging and Microscopic Analysis of Focal Chorioretinal Defects in Rabbits
Validation of an SC5b-9 Commercial Kit for Preclinical Biomarker Analysis
Correlating Changes in Body Weights and Immune System Parameters in Cynomolgus Macaques
ISSUE NO. 32 — A Changing Paradigm for Non-Rodent Species in Nonclinical Safety Studies
The choice of species for nonclinical safety studies is an important step in the drug development process. The species to be used is largely dependent on the test article type and clinical indication. Existing regulatory guidance documents, combined with careful consideration of the characteristics of the drug being developed, guided by scientific, ethical, and practical considerations, help inform this key decision.
The most common non-rodent species involved in nonclinical safety studies are nonhuman primates (NHPs) and canines. There is, however, an increasing body of evidence that supports the use of miniature swine as a viable non-rodent option for nonclinical safety studies.
In Issue 32 of The Altascientist, we take a deep dive into the benefits of miniature swine as a research model in your nonclinical studies:
- Introduction to miniature swine in preclinical testing
- Miniature swine size considerations
- Real-world examples for miniature swine use in clinical development
- Species selection criteria and processes
- Four case studies