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
Tag: PK/PD Modeling and Simulation
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
Physiologically-based pharmacokinetic modeling can be used to support bioequivalence (BE) assessment of complex and locally acting generic drugs.
As Life-Science manufacturers embrace new technologies to speed time to market and products become more complex, the FDA has created an Office of Digital Transformation (ODT) to support the effective review, approval, and regulation of human drugs, biological products, and medical devices. To achieve its goals, FDA is doubling down on cloud technologies and the … Continued
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 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