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Showing results 145 - 160 of 91813 for .

Showing results 145 - 160 of 91813 for .

In Vivo Safety Testing of Biosimilar Drugs - Recent Experiences
Society of Toxicology (SOT) 2016 -- A key element for the development of a biosimilar ("follow on") molecule, whether a monoclonal antibody (Mab) or a non-Mab protein, is the comparability of the biological activity/nonclinical to the marketed (innovator) drug. A range of regulatory guidelines exist to assist drug companies in developing a biosimilar molecule, whether an Mab or a non-Mab protein. A key consideration is biological activity/nonclinical comparability to the marketed drug.
Long-Term Intrathecal Bolus Administration Studies in Cynomolgus Monkeys: Expected Background Findings, Procedure-Related Observations and Recommended Procedures
Society of Toxicology (SOT) 2016 -- Nonclinical studies in cynomolgus monkeys involving direct lumbar cerebrospinal fluid (CSF) administration under anaesthesia are fundamentally different from studies with more conventional routes and several important points should be considered with their design especially at time of study report generation. Preclinical safety studies on Central Nervous System (CNS) administered compounds must differentiate between the effects of the compound, the...
Diagnostic Tools to Enhance Long-Term Intrathecal Delivery Studies in Nonhuman Primates
Society of Toxicology (SOT) 2016 -- While direct Central Nervous System (CNS) administration is likely to evolve as a delivery route in the treatment of neurodegenerative disorders, preclinical development of potential CNS therapeutics in nonhuman primates faces a number of challenges. Preclinical safety studies on CNS administered compounds must differentiate between the effects of the compound, the delivery technique and side effects caused by factors unrelated to test compound, such as...
Development of a PD-1 Receptor Occupation Method in Cynomolgus Whole Blood
Society of Toxicology (SOT) 2016 -- Recent years have seen an increase in "checkpoint inhibitors" as potential therapies for a variety of malignancies. One checkpoint inhibitor of particular interest is the PD-1 cell surface protein expressed on activated T cells. Binding of PD-1 by its ligand PD-L1 has been shown to induce apoptosis in activated T cells and this mechanism has been exploited by certain malignancies evading immune surveillance.
Physiologically Based Parent-Metabolite Pharmacokinetic Modeling of Morphine and Metabolites in Monkeys after IV and Oral Administration of Morphine Sulfate
SOT 2017 - This project was to investigate the pharmacokinetics (PK) of morphine, morphine-3-glucuronide (M3G) and morphine-6-glucuronide (M6G) in plasma and urine after single intravenous and oral gavage doses of morphine sulfate in monkeys, and to develop a parent-metabolite PBPK model that incorporates the first-pass effect.
Magnetic Resonance Imaging and Computer Tomography During the Conduct of Regulatory Studies with Nonhuman Primates: Can Enhanced Imaging Secure Your Study?
SOT 2017 - The cynomolgus monkey (Macaca fascicularis) represents an important primate model for preclinical safety evaluation, as it has shown to predict toxicity and pharmacodynamics of many pharmaceuticals under development. Beside the predominant macaques, the marmoset monkey (Callithrix jacchus) in addition has proven to be an alternative nonhuman primate species for the development of biologics. The present work examined the use of multi-slice spiral computed tomography (CT) and...
Developmental Toxicity Evaluation in the Cynomolgus Monkey (Macaca fascicularis): Does Mauritian Origin Matter?
Society of Toxicology 2015 -- Recent advances in genomic typing revealed interesting insights on the genetic diversity and hybridization among different macaque species and also among cynomolgus monkeys (long-tailed macaques) of different geographic origin. The present investigation was undertaken to evaluate whether developmental toxicity parameters differ between cynomolgus monkeys of Asia mainland and Mauritian island origin.
Combining Invasive Cardiovascular Telemetry Assessment with Continuous Intravenous Infusion in Cynomolgus Monkey
Society of Toxicology 2015 -- Preclinical programs quite often require intravenous dosing either as bolus or slow bolus infusion (e.g. 15 minutes) as route of administration. In some cases, such as for compounds with short half-life or poor solubility, a continuous infusion regime over several hours might also be considered. While some guidance about the maximum feasible dose volumes is available (Diehl et al., 2001, Turner et al., 2011), relatively little is know about the volume effects...
JET-BP in Socially Housed Nonhuman Primates: Comparison of Covance Sites and Study Considerations
Society of Toxicology 2015 -- While social housing is highly desirable for enhancing animal welfare, it can introduce challenges to the collection of high-quality cardiovascular data via jacketed external telemetry with blood pressure (JET-BP). A comparison of two Covance sites was undertaken to evaluate the consistency of JET-BP assessments in ETS 123 compliant pens across sites.
Detection of IgG and IgM Responses to Hepatitis B Antigen in the Cynomolgus Monkey
Society of Toxicology (SOT) 2016 -- The T-cell dependent antibody response (TDAR) assay has become a standard approach to assess immune function. The successful TDAR is dependent on multiple functional immune processes. Antigen uptake and presentation by antigen presenting cells is followed by T-cell recognition and B-cell activation to produce antibodies. Alteration of any of these processes will result in abnormal antibody production and indicate the occurrence of immunomodulation. For...
2014 Scientific Posters for Safety Assessment
2014 Scientific Posters for Safety Assessment
Germ Cell Pig-a Assay: A Trans-Tissue Application of the In Vivo Gene Mutation Assay
SOT 2017 - Mutations transmitted though germ cells are of particular concern since they will occur in every cell of resulting offspring, and thus can have a profound impact on the phenotype. Thus the analysis of germ cell genotoxicity and gene mutation is sometimes recommended under particular circumstances. In addition to cells of the bone marrow, male germ cells are actively dividing in adults, and can be made into single cell suspensions, making them potentially amenable for the...