International Harmonization of Nomenclature and Diagnostic Criteria (INHAND): Nonproliferative and Proliferative Lesions of Nonrodent Ocular Tissues [0.03%]
国际命名和诊断标准的协调(INHAND):非啮齿类动物眼组织的非增生性和增生性病变
K A Schafer,E Atzpodien,U Bach et al.
K A Schafer et al.
The INHAND (International Harmonization of Nomenclature and Diagnostic Criteria for Lesions) Project (www.toxpath.org/ inhand.asp) is a joint initiative of the Societies of Toxicologic Pathology from Europe (ESTP), Great Britain (BSTP), Jap...
A Pathologist's Guide to Non-clinical Safety Assessment of Adoptive Cell Therapy Products [0.03%]
细胞治疗产品非临床安全性评价病理学指南
Alessandra Piersigilli,Vinicius S Carreira,Frédéric Gervais et al.
Alessandra Piersigilli et al.
Through two decades of research and development, adoptive cell therapies (ACTs) have revolutionized treatment for hematologic malignancies. Many of the seven US Food and Drug Administration (FDA)-approved products are proven to be a curativ...
Characterization of Pulmonary Pathology in the Golden Syrian Hamster Model of COVID-19 Using Micro-Computed Tomography [0.03%]
基于Micro-CT的黄金叙利亚仓鼠COVID-19模型肺病理学特征研究
Julita A Ramirez,Micah D Dunlap,Reyna Prosnitz et al.
Julita A Ramirez et al.
The Golden Syrian hamster is a well-characterized rodent model for severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-associated pneumonia. We sought to characterize the pulmonary disease course during SARS-CoV-2 infection (strain...
The Role of Neuropathology Evaluation in the Nonclinical Assessment of Seizure Liability [0.03%]
癫痫副作用的非临床评估中神经病理学评价的作用
Katie Sokolowski,Judy Liu,Marcus S Delatte et al.
Katie Sokolowski et al.
Test article (TA)-induced seizures represent a major safety concern in drug development. Seizures (altered brain wave [electrophysiological] patterns) present clinically as abnormal consciousness with or without tonic/clonic convulsions (wh...
Virtual Control Groups in Non-clinical Toxicity Studies: Impacts on Toxicologic Clinical Pathology Data Interpretation [0.03%]
非临床毒理学研究中虚拟对照组对毒理临床病理数据解读的影响
Adeyemi O Adedeji,Adi Wasserkrug Naor
Adeyemi O Adedeji
One of the emerging concepts on the reduction of animal use in non-clinical studies is the use of virtual control group (VCG) to replace concurrent control group (CCG). The VCG involves the generation of a control data from historical contr...
Toxicologic Pathology Forum*: Opinion on Assessing and Communicating Adversity for Implantable Medical Devices [0.03%]
毒理病理学论坛*:关于可植入医疗器械的 adversity评估和沟通的意见
L M Wancket,B Bolon,K A Funk et al.
L M Wancket et al.
Medical devices are a product class encompassing many materials and intended uses. While adversity determination is a key part of nonclinical safety assessments, relatively little has been published about the unique challenges encountered w...
Session 4: mRNA and Self-Amplifying RNA (saRNA): Opportunities for Disease Prevention and Therapy [0.03%]
第四场会议:mRNA和自我放大RNA(saRNA):疾病预防与治疗的机会
Rani S Sellers,Lila Ramaiah,Sue-Jean Hong et al.
Rani S Sellers et al.
The unprecedented speed of developing vaccines against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), responsible for the COVID-19 pandemic, has propelled mRNA technologies into the public eye. The versatility of mRNA tec...
Systemic Toxicity of Recombinant Adeno-Associated Virus Gene Therapy Vectors [0.03%]
重组腺相关病毒基因治疗载体的全身毒性
Basel T Assaf
Basel T Assaf
Recombinant adeno-associated virus (rAAV) vectors have emerged as a promising tool for gene therapy. However, the systemic administration of rAAV vectors is not without risks, particularly for dose levels >1 × 1014 viral genome per kilogra...
Opinion on the Importance of Sharing Toxicologic Pathology Data for Educational and/or Scientific Purposes [0.03%]
毒理病理学数据用于教育和/或科学用途的重要性评论
Eveline de Rijk,Phaedra Cole,Anna-Lena Frisk et al.
Eveline de Rijk et al.
Sharing pathology data is critical for educational and scientific purposes. Since most pharmaceutical or (agro)chemical companies outsource nonclinical safety assessment studies to contract research organizations (CROs), the pathology data ...
Historical Control Background Incidence of Spontaneous Nonneoplastic Lesions of Sprague Dawley Rats in 104-Week Carcinogenicity Studies [0.03%]
历史对照背景值SD大鼠24月致癌试验中自发性非肿瘤病变发生情况
Marie Bockenstedt,Amit Kumar,Victoria Laast et al.
Marie Bockenstedt et al.
Microscopic observation data collected from approximately 1800 male and female Sprague Dawley (SD) control rats used on 104-week carcinogenicity studies performed at North American Labcorp Early Development, Inc, Madison, WI, were retrospec...