Pigs and Ferrets as Models in Toxicology and Biological Safety Assessment

2000 ◽  
Vol 19 (3) ◽  
pp. 149-168 ◽  
Author(s):  
Shayne C. Gad
Keyword(s):  
Animal Models ◽  
Drug Development ◽  
Safety Assessment ◽  
Key Factors ◽  
Biological Safety

Both the pig and the ferret are used as animal models in toxicology and drug development, with the pig having been subject to a significant increase in usage (particularly in Europe) over the last 5 years. These two species are quite different from primates and dogs, the “standard” nonrodent models. This article seeks to both survey the rationales for and extent of use of the pig and ferret, and to highlight consideration and key factors in their use in studies.

scholarly journals Qualification of translational safety biomarkers

2021 ◽  
pp. 153537022110021
Author(s):  
John-Michael Sauer ◽  
Amy C Porter
Keyword(s):  
Skeletal Muscle ◽  
Drug Development ◽  
Vascular Injury ◽  
Validation Studies ◽  
Safety Assessment ◽  
Regulatory Agencies ◽  
Development Studies ◽  
Clinical Validation ◽  
Development Tools ◽  
Important Drug

Safety biomarkers are important drug development tools, both preclinically and clinically. It is a straightforward process to correlate the performance of nonclinical safety biomarkers with histopathology, and ideally, the biomarker is useful in all species commonly used in safety assessment. In clinical validation studies, where histopathology is not feasible, safety biomarkers are compared to the response of standard biomarkers and/or to clinical adjudication. Worldwide, regulatory agencies have put in place processes to qualify biomarkers to provide confidence in the manner of use and interpretation of biomarker data in drug development studies. This paper describes currently qualified safety biomarkers which can be utilized to monitor for nephrotoxicity and cardiotoxicity and ongoing projects to qualify safety biomarkers for liver, skeletal muscle, and vascular injury. In many cases, the development and use of these critical drug development tools is dependent upon partnerships and the precompetitive sharing of data to support qualification efforts.

Aggregate Safety Assessment Planning for the Drug Development Life-Cycle

2021 ◽  
Author(s):  
Barbara A. Hendrickson ◽  
William Wang ◽  
Greg Ball ◽  
Dimitri Bennett ◽  
Amit Bhattacharyya ◽  
...  
Keyword(s):  
Life Cycle ◽  
Drug Development ◽  
Safety Assessment ◽  
Development Life Cycle

scholarly journals Biological Safety Assessment of Functional Activated Carbons Prepared from Three Agricultural Wastes

2014 ◽  
Vol 59 (2) ◽  
pp. 321-331
Author(s):  
Han Chien Lin ◽  
Li-Ying Tseng ◽  
Ying-Jang Lai ◽  
She-Ching Wu ◽  
Noboru Fujimoto
Keyword(s):  
Safety Assessment ◽  
Activated Carbons ◽  
Agricultural Wastes ◽  
Biological Safety

scholarly journals Pathology Study Design, Conduct, and Reporting to Achieve Rigor and Reproducibility in Translational Research Using Animal Models

ILAR Journal ◽  
2018 ◽  
Vol 59 (1) ◽  
pp. 4-12 ◽  
Author(s):  
Jeffrey I Everitt ◽  
Piper M Treuting ◽  
Cheryl Scudamore ◽  
Rani Sellers ◽  
Patricia V Turner ◽  
...  
Keyword(s):  
Animal Models ◽  
Best Practices ◽  
Translational Research ◽  
Safety Assessment ◽  
Animal Studies ◽  
Animal Experiments ◽  
Study Data ◽  
Track Record ◽  
Preclinical Animal Models

AbstractIn translational research, animal models are an important tool to aid in decision-making when taking potential therapies into human clinical trials. Recently, there have been a number of papers that have suggested limited concordance of preclinical animal experiments with subsequent human clinical experience. Assessments of preclinical animal studies have led to concerns about the reproducibility of data and have highlighted the need for an emphasis on rigor and quality in the planning, conduct, analysis, and reporting of such studies. The incorporation of a wider role for the comparative pathologist using pathology best practices in the planning and conduct of animal model-based research is one way to increase the quality and reproducibility of data. The use of optimal design and planning of tissue collection, incorporation of pathology methods into written protocols, conduct of pathology procedures using accepted best practices, and the use of optimal pathology analysis and reporting methods enhance the quality of the data acquired from many types of preclinical animal models and studies. Many of these pathology practices are well established in the discipline of toxicologic pathology and have a proven and useful track record in enhancing the data from animal-based studies used in safety assessment of human therapeutics. Some of this experience can be adopted by the wider community of preclinical investigators to increase the reproducibility of animal study data.

scholarly journals Correction: A standardised framework to identify optimal animal models for efficacy assessment in drug development

PLoS ONE ◽  
2019 ◽  
Vol 14 (7) ◽  
pp. e0220325 ◽  
Author(s):  
Guilherme S. Ferreira ◽  
Désirée H. Veening-Griffioen ◽  
Wouter P. C. Boon ◽  
Ellen H. M. Moors ◽  
Christine C. Gispen-de Wied ◽  
...  
Keyword(s):  
Animal Models ◽  
Drug Development ◽  
Efficacy Assessment
Sign in / Sign up

Export Citation Format

Share Document