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Tag: PK/PD Modeling and Simulation

eChalk Talk: Avoid getting “lost in translation” – Increase confidence in translational research using biosimulation

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One of the pivotal milestones of early drug development is obtaining approval for an investigational new drug application (IND). A proposed first-in-human (FIH) study design is required for every IND application, of which a robust FIH dose rationale is a critical component. Physiologically-based pharmacokinetic (PBPK) modeling is a methodology based upon in-depth mechanistic understanding of … Continued

Simcyp Discovery Simulator

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Tailored for discovery and translational scientists, Simcyp Discovery Simulator is an intuitive software that delivers confidence in decision-making during the pre-Investigational New Drug (IND) application and translational development. Simcyp Discovery is based on physiologically-based pharmacokinetic (PBPK) modeling and simulation, a regulatory-adopted, versatile tool in drug development that helps answer a myriad of “what if” questions … Continued

Certara to Acquire Pinnacle 21, a Leader in Data Standardization Software for Pharmaceutical Clinical Data

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Transaction expected to be accretive to Certara’s revenue, revenue growth and adjusted EBITDA margin Princeton, N.J., August 5, 2021 – Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced it has signed a definitive agreement to acquire Pinnacle 21 for $310 million in cash and stock. Pinnacle 21’s software tools are used to … Continued

A Drug Development Software and Services Overview with a Focus on RsNLME and Simcyp

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A successful drug product must demonstrate drug substance viability, clinical viability, and economic viability. Drug developers typically use a range of software tools to help demonstrate the viability of their products in these domains. In this product theatre, Drs. Hannah Jones and Keith Nieforth will explain how Certara’s products and services can help accelerate the … Continued

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