A5063757212- Immunotoxicology and immune responses
- Animal testing and alternatives
- Hepatitis B Virus Studies
- Cell Image Analysis Techniques
- Carcinogens and Genotoxicity Assessment
- Viral gastroenteritis research and epidemiology
- Hepatitis Viruses Studies and Epidemiology
- Neuroinflammation and Neurodegeneration Mechanisms
- Primate Behavior and Ecology
- Reproductive Biology and Fertility
- Plant tissue culture and regeneration
- Virus-based gene therapy research
- Amyotrophic Lateral Sclerosis Research
- CAR-T cell therapy research
- Biomedical Ethics and Regulation
- Mediterranean and Iberian flora and fauna
- Trace Elements in Health
- Inhalation and Respiratory Drug Delivery
- Biosimilars and Bioanalytical Methods
- Drug-Induced Hepatotoxicity and Protection
- Sperm and Testicular Function
- Drug-Induced Adverse Reactions
- Pharmacogenetics and Drug Metabolism
- Ocular Diseases and Behçet’s Syndrome
- Mycobacterium research and diagnosis
Covance (Germany)
2016-2021
The Cause of Death in Non-Rodents (CODN) Working Group is an initiative under the Scientific and Regulatory Policy Committee (SRPC) Society Toxicologic Pathology (STP), focused on understanding existing practices expectations among pharmaceutical companies, academic entities, contract research organizations (CROs) when it comes to identifying reporting “Cause Death” (COD) or moribundity for early unplanned necropsies non-rodent animal species (mainly non-human primates [NHP] dogs) within...
Despite extensive clinical research, the etiology of equine recurrent uveitis (ERU) is still unknown. After an immunologic pathogenesis was established in humans, a similar pathogenic mechanism assumed to exist ERU. To investigate whether immunopathologic mechanisms are involved ERU, 20 eyes 15 horses with ERU were examined immunohistochemically T cell marker, B and anti-major histocompatibility complex (MHC) class II antibodies. Twenty-six used for investigation MHC antigen expression...
To investigate the influence of geographical origin, age, and sex on toxicologically relevant spontaneous histopathology findings in cynomolgus macaques ( Macaca fascicularis), we performed a comparative analysis historical control data (HCD) from 13 test sites that included 3351 animals (1645 females 1706 males) sourced Mauritius, China, Vietnam, Cambodia, aged 2 to 9.5 years, 446 toxicology studies evaluated between 2016 2021. The most common were mononuclear infiltrates kidney, liver,...
Lysosomes have a central role in cellular catabolism, trafficking, and processing of foreign particles. Accumulation endogenous exogenous materials lysosomes represents common finding nonclinical toxicity studies. Histologically, these accumulations often lack distinctive features indicative lysosomal or dysfunction, making it difficult to consistently interpret assign adverse dose levels. To help address this issue, the European Society Toxicologic Pathology organized workshop where...
In 2014, the Organisation for Economic Co-operation and Development (OECD) issued guidance no. 16, Guidance on GLP Requirements Peer Review of Histopathology. The stated purpose document is “to provide to pathologists, test facility management, study directors quality assurance personnel how peer review histopathology should be planned, managed, documented, reported in order meet Good Laboratory Practice (GLP) expectations requirements.” On behalf collaboration with global societies...
The Society of Toxicologic Pathology (STP) explored current institutional practices for selecting between non-blinded versus blinded histopathologic evaluation during Good Laboratory Practice (GLP)-compliant, regulatory-type animal toxicity studies using a multi-question survey and STP-wide discussion (held at the 2019 STP annual meeting). Survey responses were received from 107 individuals representing 83 institutions that collectively employ 589 toxicologic pathologists. Most came industry...
This article describes the Society of Toxicologic Pathology's (STP) five recommended ("best") practices for appropriate use informed (non-blinded) versus masked (blinded) microscopic evaluation in animal toxicity studies intended regulatory review. (1) Informed is default approach studies. (2) Masked has merit confirming preliminary diagnoses target organs and/or defining thresholds ("no observed adverse effect level" and similar values) identified during an initial evaluation, addressing...
Nonclinical toxicology studies that are required to support human clinical trials of new drug candidates generally conducted in a rodent and non-rodent species. These typically contain vehicle control group low, intermediate, high dose test article groups. In addition, dosing-free recovery phase is sometimes included determine reversibility potential toxicities observed during the dosing may include additional animals one or more Typically, determined by comparing article-related changes...
Many potential drugs for treatment of neurodegenerative diseases, particularly antisense oligonucleotides (ASOs), are administered via lumbar intrathecal injection, because these do not cross the blood–brain barrier. Intrathecal injection is a well-established method in cynomolgus monkeys, species that used preclinical safety assessment when other nonrodent cannot be used. The authors completed ASO administration over 30 studies (>1000 animals and >4500 dose administrations) during...
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 of those are not owned by investigator but legal property respective company sponsoring work. Although some have installed policies that govern sharing data, many generally do allow external use either CRO-based study pathologist sponsor pathologist. Policies governing...
The indirect assessment of adverse effects on fertility in cynomolgus monkeys requires that tissue sections the testis be microscopically evaluated with awareness stage spermatogenesis a particular cross-section seminiferous tubule is in. This difficult and subjective task could very much benefit from automation. Using digital whole slide images (WSIs) testis, we have developed deep learning model can annotate each high sensitivity, precision, accuracy. was validated six WSI using six-stage...
Hepatitis A virus (HAV) infects humans and nonhuman primates, typically causing an acute self-limited illness. Three HAV genotypes have been described so far for humans, three primates. We observed transiently elevated liver enzymes in Mauritius-origin laboratory-housed macaques Germany were not able to demonstrate etiology including by serology polymerase chain reaction (PCR). is a rare pathogen cynomolgus macaques, since all employees routinely vaccinated against HAV, it was part of the...
Direct delivery of therapeutics to the central nervous system (CNS) greatly expands opportunities treat neurological diseases but is technically challenging. This opinion outlines principal technical aspects direct CNS via intracerebroventricular (ICV) or intrathecal (IT) injection common nonclinical test species (rodents, dogs, and nonhuman primates) describes procedure-related clinical histopathological effects that confound interpretation article-related effects. dosing by ICV in mice due...
ABSTRACT Hepatitis A virus (HAV) infects humans and non-human primates causing an acute self-limited illness. Three HAV genotypes have been described for three primates. We observed transiently elevated liver enzymes in Mauritius-origin laboratory-housed macaques Germany were not able to demonstrate by serology PCR. Using deep sequencing, we identified a new genotype with 86% nucleotide sequence homology IV capsid proteins approximately 80% other genotypes. In situ hybridization indicates...