药物开发的平均发现阶段持续四年半，仅有 6% 的评估化合物进入候选药物的临床前开发阶段。将药物研发的成功率提高 2%，就意味着在整个临床开发过程中节省了大量的下游直接成本和时间。In-silico drug … <a href="https://www.certara.com.cn/webinar/predict-success-faster-in-drug-discovery-designing-a-more-effective-model-for-drug-discovery-research/">Continued</a>
Physiologically Based Pharmacokinetic (PBPK) modelling is an integrative approach facilitating the optimal use of various in vitro and preclinical data to determine the first in human dose. Simcyp Discovery, a part of Simcyp family, is a user-friendly PBPK platform designed to integrate in vitro and preclinical data, enabling the prediction of drug pharmacokinetics (PK) in … <a href="https://www.certara.com.cn/webinar/physiologically-based-pharmacokinetic-modelling-an-integrative-approach-to-first-in-human-fih-studies-apac-webinar/">Continued</a>
Developing safe and effective oncology medications for children presents unique challenges due to ethical considerations and physiological differences across age groups. Traditional clinical trials often face limitations in sample size and recruitment of specific pediatric populations, hindering the efficient development of these critical drugs. This presentation explores strategies to overcome these challenges and optimize pediatric … <a href="https://www.certara.com.cn/webinar/raps-sponsored-webcast-optimizing-pediatric-oncology-drug-development-a-comprehensive-overview/">Continued</a>
In September 2023, the European Medicines Agency (EMA) reinstated its Policy 0070 requirement to publish all clinical studies submitted for regulatory approval. After almost five years of being offline (other than for COVID-19 submissions), the process and new standards for Policy 0070 will likely be new to many sponsors looking to authorize their product in … Continued
Connecting Cancer and Autoimmunity “The dosing regimens in oncology may not directly inform the optimal choices in autoimmune diseases from an efficacy or safety perspective.” The level of immune activation is enormously influential for the progression of both cancer and autoimmune diseases (Elkoshi, 2022). While acting in opposite extremes, the common biological pathways have hinted that … Continued
Background Monkeys and humans share a strong bond, reflected not only in a shared genetic heritage, but in history and folklore. In Chinese literature from the 16th century, Journey to the West (Xi You Ji) tells a famous story of a Buddhist monk named Tang Seng during his journey to obtain sacred Buddhist texts. Tang Seng is … Continued
Certara 提供先进的药物开发解决方案，帮助制药和生物技术公司加快从早期研究到成功获得市场批准的过程。Certara 的专家团队中不乏世界领先的科学家，其中有七位科学家在他们各自的领域中被公认为被引用次数最多的前 2% 的科学家*。我们带给客户的价值在于与业内规模最大的模型引导的药物开发团队合作，降低项目风险，缩短时间线，降低成本，并提高对新的疗法如何影响患者的科学理解。Certara 拥有灵活的操作模式，支持大型制药企业中的专业建模团队，并为新兴生物科技初创公司担任全面的药物开发管理者，为客户提供卓越的价值，助您快速前进。
Certara 软件产品包括行业黄金标准产品，已在全球超过 60,000 名最终用户中使用。我们的目标是利用先进的计算能力引领行业，改变药物开发模型，包括药物发现、生物模拟和临床数据自动化。
模型 系统药理学模型以基本质量-作用、机制 PK/PD 常微分方程系统的第一原理为基础。The model parameters and reactions include compartment volumes, ligand concentration and turnover rates, cell numbers and turnover rates, drug administration, target-mediated drug disposition on two cell types, and endogenous drug elimination (Figure 2). Continued
Highlights ⬇️ Who are CDISC? ⬇️ Where our partnership began ⬇️ Encouraging the adoption of CDISC standards ⬇️ Visualizing CRFs for EDC Systems Who are CDISC? The Clinical Data Interchange Standards Consortium (CDISC) began in 1997 as a grassroots initiative, in response to the need to better structure and improve the quality and consistency of … Continued
全球有超过 2,300 家生命科学公司，包括 23 家全球监管机构，选择 Certara 作为他们在 MIDD 解决方案方面的合作伙伴，这些解决方案包括生物模拟、数据科学软件和专业的药物开发服务。了解我们如何帮助公司重新定义现代医学的可能。
