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从概念到市场:MIFD 和 Simcyp Biopharmaceutics 在简化药物制剂和审批方面的价值

网络研讨会

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 & Simulation, PK Sciences at NIBR at Novartis.

We’ll explore the latest advancements in small molecule model-informed formulation development (MIFD) technology, covering topics from early formulation selection to virtual bioequivalence (VBE) assessments.

参加此次网络研讨会,您将在以下方面有所收获:

简化开发流程: Learn how Simcyp Biopharmaceutics accelerates formulation identification and refinement, saving time and resources.

增强决策: Discover how to use Simcyp Biopharmaceutics to make informed choices about incorporating advanced technologies into your workflows.

广泛的适用性: Explore real-world use cases demonstrating the software’s effectiveness from early formulation selection to virtual bioequivalence assessments.

独特的应用: Gain insights into Simcyp Biopharmaceutics’ innovative features like the Virtual Bioequivalence (VBE) module, advanced GI modeling, and automated safe space identification.

MIFD 的价值: Understand how Model-Informed Formulation Development (MIFD) with Simcyp Biopharmaceutics expedites formulation refinement and increases biowaiver success rates, leading to faster drug development.

本次网络研讨会对以下人员最有帮助:

  • Biopharmaceutics scientists
  • 药物制剂专家
  • Pharmaceutical professionals involved in drug development
  • 对创新制剂战略感兴趣的研究人员和行业利益相关者

注册报名
Presenters and Guest Panelists
ks profile
Kazuko Sagawa, Ph.D.
Research Fellow, Pfizer Global Research and Development
Dr. Sagawa is a Research Fellow in the Pharmaceutical Science Department at Pfizer Research and Development in Groton Connecticut. As a member of a multidisciplinary team within Pfizer, she has been involved in developing biopharmaceutics strategy for drug product development. The work includes biopharmaceutics risk assessment, PBPK model development, and clinical bioequivalence risk assessment. Dr. Sagawa received her B.Sc in Pharmacy from Tokyo University of Pharmacy and Life Sciences (Tokyo Japan) and her Ph.D. in Pharmaceutical Sciences from the University of New York at Buffalo (Buffalo, NY)
David Turner 2024
David B. Turner, PhD
高级首席科学家

David B. Turner , PhD于 2004 年加入 Simcyp,现任 Certara UK Ltd(Simcyp 部门)高级科学顾问兼口服吸收机制建模总监。他是 44 篇同行评审论文的作者或合著者。他在 Simcyp 的工作主要集中在口服吸收建模,但也涉及 PBPK 建模的物理化学模块,包括组织分布和各种 QSAR 模型。David 最近作为首席研究员完成了一项 FDA 资助项目,该项目旨在开发处理过饱和药物产品的建模工具,他还是另一项 FDA 资助项目的共同首席研究员,该项目旨在研究消化道局部作用药物。他在英国谢菲尔德大学获得了生物化学学士学位、计算机科学硕士学位以及化学信息学和 QSAR 建模博士学位。加入 Simcyp 之前,他曾在一家计算化学机构(Synt:em SA,法国尼姆)工作,主要负责高通量计算机模拟发现和虚拟筛选项目。

Nikunjkumar Patel
Nikunjkumar Patel, PhD
Senior Director of PBPK Consultancy Services
Dr. Patel 是 Certara 公司 Simcyp 部门 PBPK 咨询服务高级总监。Nikunj 帮助客户进行先进的 PBPK 建模,以加快内部决策,通过虚拟生物等效性评估支持生物豁免,并为新产品、非专利制剂、扩大规模和批准后变更 (SUPAC) 以及溶出度规格的合理性制定以模型为依据的监管策略。他在计算机辅助药物设计和 PKPD 建模方面拥有超过 15年的经验,其中包括13年以上专注于 PBPK 建模的经验。

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