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Advance your preclinical oncology compounds with a comprehensive suite of preclinical oncology studies, including in vitro and in vivo pharmacology efficacy models, in vivo imaging technologies as well as focal radiation capabilities.

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吸入toxicology studies are becoming vital in assessing the safety and potential toxicity of inhaled drugs or chemicals as respiratory diseases including asthma, chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF) become more common.

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发展景观变得越来越复杂。您仍然需要您的学习按时和预算。通过将鼓舞人心的科学与数据连接,我们忠诚的科学团队从临床前和临床研究中发现了见解,以帮助您到达您的发展里程碑。yaboapp体育官网

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Preclinical supported 81% of the FDA's 2019 NDA/BLA drugs
Preclinical supported 77% of the FDA's 2019 biologics
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用新型干细胞疗法治疗年龄相关的黄斑变性(AMD)
用新型干细胞疗法治疗年龄相关的黄斑变性(AMD)
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大胆的目标为regenerat倡议(AGI)ive medicine is a program run by the National Eye Institute (NEI), aimed at finding new therapies for eye diseases that remain difficult to treat. Age-related macular degeneration is the leading cause of vision loss in the US, affecting 2.5% of the population, most over the age of 50.
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A comparison of FDA, EMA & PMDA regulatory guidance for in vitro drug-drug interaction (DDI) assessments
A comparison of FDA, EMA & PMDA regulatory guidance for in vitro drug-drug interaction (DDI) assessments
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This whitepaper article explores the 2020 regulatory changes in U.S. FDA guidance1 and recommendations, compared to existing EU EMA2 and Japanese PMDA3 guidance for in in vitro drug-drug interaction (DDI) assessments. The Evolving Regulatory Landscape Since 1997 the regulatory agencies, FDA, EMA and PMDA have endorsed the use of in vitro metabolism studies to assess the DDI potential of new chemical entities (NCE). Over the past 10 years, however, scientific progress has been rapid, fueled by sophisticated in vitro models and in silico predictive programs.
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Assessment of Potential Drug-Drug Interactions from In Vitro Experiments to PBPK Modeling
Assessment of Potential Drug-Drug Interactions from In Vitro Experiments to PBPK Modeling
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FDA最近批准了毒品 - 药物相互作用(DDI)的更新监管指导。本次网络研讨会将专注于如何遵循FDA指导,设计体外研究,使用静态和生理学的药代动力学(PBPK)模型来评估数据并评估潜在的药物 - 药物相互作用。我们还将分享我们的解释,因为监管机构建议计算不同方法,以计算包括静态和PBPK模型的DDI潜力。多种药物的共同施用可能导致药物 - 药物相互作用(DDI),其中一种药物改变另一个药物,导致治疗失败或患者生命的风险。在体外研究是评估潜在DDI的关键,因为它们具有成本效益,节省时间,并且可以帮助理解DDI的机制,并为临床试验提供指令(由于高成本,临床试验不应用于筛选潜在DDIS,冗长的持续时间和道德考虑,但它们应该用来确认从体外研究和相应的建模推荐的潜在DDIS)。
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在Vitro Cytokine Release Assays: Is There Calm After the Storm? | CRA Post I
在Vitro Cytokine Release Assays: Is There Calm After the Storm? | CRA Post I
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Cytokine Release Syndrome (CRS), otherwise known as cytokine storm, is a systemic inflammatory response caused by complications due to disease, infection or an adverse effect of biologic therapy. The clinical symptoms of a cytokine storm are massive release of a potent cocktail of pro-inflammatory cytokines into the general circulatory system, leading to severe multi-organ damage, failure or potentially death. This is an extremely unwanted immunotoxicological side effect in drug development.
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