概述
Predicting how a drug product will behave in vivo (e.g., accounting for gastric pH, food effects, population variability, etc.) is a central challenge across drug development, whether for a new molecule or a generic. Generics carry an added constraint: reproducing a reference product’s performance without seeing its formulation and clearing a narrow bioequivalence bar under tighter timelines and thinner margins than innovator programs allow.
Model-informed formulation development (MIFD) offers a mechanistic, data-driven path through these challenges. In this webinar, we’ll present the latest features in Simcyp® Biopharmaceutics V25 and real-world case studies applying MIFD.
Key learning objectives:
- Receive an overview of Simcyp Biopharmaceutics, Certara’s software platform for small molecule drug development, including recent capability updates relevant to formulation strategy and biowaiver support
- Learn how mechanistic PBPK modeling was applied in a recent Molecular Pharmaceutics publication to evaluate pH-modifying excipient effects and inform formulation design decisions aimed at mitigating pH-mediated drug-drug interactions
- Understand the role of self-buffering nature of the drugs (free forms and salts), the mechanisms by which pH-modifying excipients overcome elevated pH effects of ARAs, and the role of buffers
- Learn the factors that need consideration when developing pH-DDI mitigating formulations using either salt forms or pH-modifying excipients
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Siri Kalyan Chirumamilla
Siri Kalyan Chirumamilla is an Associate Principal Scientist at Certara UK Limited (Simcyp Division) with focus on absorption modelling of oral drug products. He was the lead for Expansion of IVIVC, Virtual Bioequivalence (VBE) and Oral absorption Projects for Simcyp Simulator. He is currently leading the development of Simcyp Biopharmaceutics software. Prior to joining Simcyp in 2018, he worked for about 5 years as a Formulation Scientist, responsible for developing Oral drug products for both ANDA and 505b2 applications in Dr. Reddy’s Laboratories. He received his master’s degree from National Institute of Pharmaceutical Education and Research (NIPER S.A.S Nagar), India.
David B. Turner, PhD
Senior Scientific Advisor & Head of Mechanistic Oral Absorption ModellingDavid 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。
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