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Computational neurosciences and quantitative systems pharmacology: a powerful combination for supporting drug development in neurodegenerative diseases

Successful clinical development of new therapeutic interventions is notoriously difficult, especially in neurodegenerative diseases, where predictive biomarkers are scarce and functional improvement is often based on patient’s perception, captured by structured interviews. As a consequence, mechanistic modeling of the processes relevant to therapeutic interventions in CNS disorders has been lagging behind other disease indications, probably … Continued

QSP Designer: Quantitative systems pharmacology modeling with modular biological process map notation and multiple language code generation

Typical Quantitative Systems Pharmacology (QSP) workflows involve discussion of biology, supported by graphical diagrams, followed by construction of large Ordinary Differential Equation models. QSP Designer facilitates this process by providing enhanced graphical notation, which enables hierarchical presentation with modules and handling of combinatorial complexity with diagram node arrays. Whereas the software includes a simulation engine, … Continued

Exposure-Response Analyses of Tremelimumab Monotherapy or in Combination with Durvalumab in Patients with Unresectable Hepatocellular Carcinoma

An novel single dose regimen of tremelimumab combined with durvalumab could be a way to treat unresectable hepatocellular carcinoma. In this recently published Clinical Cancer Research study, co-authored by Certara’s Rajesh Krishna, the findings reveal that overall survival was longer for patients given this drug regimen.

Opening a debate on open‐source modeling tools: Pouring fuel on fire versus extinguishing the flare of a healthy debate

As model‐informed drug development becomes an integral part of modern approaches to the discovery of new therapeutic entities and showing their safety and effectiveness, modalities of incorporating the paradigm into widespread practice require a revisit. Traditionally, modeling and simulation (M&S) have been performed by specialized teams who (…)

BPS Article: Model‐Informed Drug Repurposing: a Pharmacometric Approach to Novel Pathogen Preparedness, Response and Retrospection

Abstract During a pandemic caused by a novel pathogen (NP), drug repurposing offers the potential of a rapid treatment response via a repurposed drug (RD) while more targeted treatments are developed. Five steps of model‐informed drug repurposing (MIDR) are discussed: i) utilize RD product label and in vitro NP data to determine initial proof of potential, ii) … Continued

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