增强药物开发的确定性

本网络研讨会以日语进行。Certara introduced D360, a drug discovery research platform, focusing on its functional features such as no-code data collection, assay result display, chemical structure and sequence handling and analysis, uploading of unregistered data at the review stage, and analysis capabilities. To provide total solutions including services in pharmaceutical &hellip; <a href="https://www.certara.com.cn/webinar/technologies-for-the-analysis-and-utilization-of-vast-amounts-of-data-in-drug-discovery-research-japan-webinar/">Continued</a>

eCTD v4.0 establishes the use of keywords in the metadata as well as introduces the new harmonized submissionunit.xml.&nbsp; Together with modifications to the eCTD granularity, these changes present the familiar eCTD modules in a whole new way.&nbsp; Join us as we explore the evolution of the submission structure and discover the importance of savvy software &hellip; <a href="https://www.certara.com.cn/webinar/ectd-4-0-exploring-the-submission-structure/">Continued</a>

Free Webinar for Biopharmaceutics and Drug Formulation Scientists Join us for an insightful discussion with Pfizer experts Vivek Purohit, Sr. Director and Pharmacometrics Team Leader for Inflammation and Immunology, and Kazuko Sagawa, Research Fellow in the Biopharmaceutics Group, along with Ioannis Konstandtinidis, Principal Scientist II Modeling &amp; Simulation, PK Sciences at NIBR at Novartis. We&#8217;ll &hellip; <a href="https://www.certara.com.cn/webinar/from-concept-to-market-value-of-mifd-simcyp-biopharmaceutics-for-streamlined-drug-formulation-and-approvals/">Continued</a>

利用人工智能简化临床试验和药物发现 随着生成式人工智能（GEN AI）的引入，药物开发领域正在演变，为创新和效率提供了无与伦比的机会。生成式 AI 技术利用自然语言处理（NLP）从现有数据中创建新的文本。以下是 Axendia 市场研究报告：“生成式 AI 的现状 … Continued

罕见病的新疗法开发既是机遇，也很复杂。由于这些适应症中可用的患者群体较小，因此在设计、进行临床试验及随后的数据解释以及最终的注册道路上都面临着挑战。罕见疾病开发中排名前 3 关键失败原因包括：理解不足 …Continued

风险分类 从申办方在全球任何国家首次获得授权进行药物临床试验开始，他们必须每年准备并提交药物开发安全更新报告（DSURs）。DSUR 的目的是对申办方研究药物相关的安全信息进行全面评估。这是安全评估的强制部分 … Continued

技术进步和监管环境的变化导致药物申请发生了变化，从仅仅包括一系列随机临床试验（RCTs）到 RCTs 加上真实世界数据（RWD）和各种非干预性研究设计的数据。大多数获得批准的新药申请（NDAs）和生物制品许可申请（BLAs）都 … Continued

监管文件撰写是药物开发过程中的重要组成部分。监管文件撰稿人必须理解科学概念以及最新的法规和指导原则，以编写符合要求的监管文件。因此，为药物项目编写所需的文件可能会耗费大量时间并容易延误。在过去的二十年里，监管文件撰写实践已经 … Continued