Showing results 129 - 144 of 91813 for .
Showing results 129 - 144 of 91813 for .
Addressing the Drug Development Gap in China
Each year, new medicines are launched globally but few are available to Chinese patients, in comparison to those in the US or EU. Drug developers are working to reduce this gap and expand the reach of new molecular entities (NMEs) so that they can improve healthcare to patients in need.
Facing the Storm In Stride
When it comes to clinical trials, sample collection kits need to arrive on time, or precious samples will not be able to be tested within stability, meaning their data is irretrievably lost. Adverse weather events and other disruptions to the sample chain of transport represent a serious threat to specimen stability and data integrity…
The Evolution of Open-Label Extensions and Rare Disease Studies
When running early development studies, sponsors must consider whether or not to provide open-label, long-term treatment at the end of their randomized, placebo-controlled trial.
Accelerating Rare Disease and Orphan Drug Development: Opportunities for Biomarkers, Diagnostics & Patient Engagement
Rare diseases affect more than 350 million people worldwide but patients often face limited Covance Labs Rare and Orphan Drug Development DNA Strand options for approved therapies. As a result, many patients have joined advocacy groups first and foremost to connect with others struggling with their disease, but also to promote research, unite multiple stakeholders and stimulate new possibilities in the therapeutic pipeline.
Capitalizing on Global Drug Development Opportunities from China
The Chinese pharmaceutical market continues to grow steadily, but drug developers in Covance China Drug DevelopmentChina face similar challenges as their global counterparts: Development times are increasing and success rates are declining. Xiaoning Guo, PhD, PMP, clinical development program director of Covance Asia Pacific, recently discussed potential strategies to improve investment returns and accelerate global development.
Clinical Outcomes in NASH: Choosing the Right Endpoints
A range of liver-related outcomes: NASH patients face many potential disorders and complications. In addition to overall death and liver-related mortality, the following endpoints should be evaluated in a clinical comes study...
What Are the Emerging Noninvasive Biomarkers in NASH?
Novel biomarkers represent a promising means to improve diagnosis of nonalcoholic steatohepatitis (NASH). Currently, a definitive diagnosis requires a liver biopsy, a surgical Covance NASH Liver Disease Blogprocedure with many limitations. There are a variety of biomarkers that can assess liver status, but they do not always distinguish between patients with NASH and those with other disorders. Advanced imaging techniques, while useful for evaluating some liver features, can be impractical...
How to Navigate Pre-Clinical Issues in NASH Development
The pre-clinical phase of development for non-alcoholic steatohepatitis (NASH) drugs faces many challenges. Biopharmaceutical companies have several options for rodent models, but they must weigh factors such as customization versus speed before deciding on the best approach.
The Shift Toward More-Personalized Medicine in China
Chinese biopharmaceuticals are expanding development beyond generics to focus on Covance Drug Development China 4producing more novel therapies, biomarkers and companion diagnostics. Steven Anderson, PhD, chief scientific officer at Covance, recently discussed his thoughts on biomarkers and precision medicine in China's drug development and translational medicine landscape.
Juvenile Toxicity Testing in Nonhuman Primate Models: Challenges and Experiences
Society of Toxicology 2015 -- We have experienced an increased demand for the use of the NHP model in pediatric testing plus the occasional need to resort to non-standard routes of delivery (e.g. intrathecal). An overview of studies with the testing considerations they evoked are presented here.
Improving 3R Application in Regulatory Testing
Society of Toxicology 2015 -- On the principle of the 3Rs to Replace animals, to Reduce the number of animals used and to improve the experimental conditions (Refinement), a real willingness to work together exists between researchers, technicians and ethics committee, realizing that ethics is not only a regulatory requirement but that each team member has something to gain in a collaborative approach that contributes to its success.
Is Open Discussion on Animal Research Beneficial to Science and the Industry?
Society of Toxicology 2015 -- In the past few years there has been an initiative toward openness to expand the knowledge base of the general public and increase their understanding of why, when and how we use animals in research.
Correlation of the Pig-a Assay with Regulatory Genetic Toxicology Endpoints
Society of Toxicology (SOT) 2016 -- Caffeic acid is present in a variety of fruits, vegetables and seasonings. It is considered to be a possible human carcinogen (Group 2B, IARC). It is negative in the Ames assay, positive for chromosome aberrations in CHO cells and negative for micronuclei (MN) in mouse bone marrow. The Pig-a assay could be a useful follow-up for compounds that produce an equivocal or weak positive response in the Ames and/or in vitro mammalian cell cytogenetic assays.
Detection of DNA Cross-Links in Rat Liver and Kidney in the In Vivo Alkaline Comet Assay
Society of Toxicology (SOT) 2016 -- In 2014, OECD published a test guideline for the conduct of the in vivo alkaline comet assay in rodents (OECD TG 489). The alkaline comet assay detects DNA strand breaks, which can be indicative of many genotoxic events; however, significant modifications to the test guideline protocol are required if DNA crosslinks are suspected as these cannot be reliably detected under standard conditions.
Ocular Tolerability of iPSC-Derived RPE Following Subretinal Administration in RNU Nude Rats
SOT 2017 - Dysfunction of retinal pigment epithelial (RPE) cells is a key factor in development of age related macular degeneration. RPE supports photoreceptor function, and degeneration of RPE leads to retinal degeneration and vision loss. RPE replacement therapy has the potential to stop such degeneration. A subretinal implant composed of induced pluripotent stem cell (iPSC)-derived RPE cultured on a biocompatible poly (lactic-co-glycolic acid; PLGA) scaffold is currently in development...
Emerging Biologics Development Methods: Free-Ranging Cynomolgus Monkeys Undergoing Continuous Intravenous Infusion with an Implanted Port Catheter System - A Method Transfer in Courtesy to the ...
Society of Toxicology (SOT) 2016 -- Numerous pharmaceuticals and recently an increasing list of monoclonal antibodies undergoing regulatory preclinical trials in nonhuman primates are administered intravenously, often by continuous infusion. In consideration of "Refinement" in the 3 Rs, an existing infusion technique was required to be transferred to a new laboratory setting.