A FRIENDS OF CANCER RESEARCH WHITE PAPER The article explores the complex landscape of determining optimal drug doses in early-phase oncology trials, with a focus on achieving a delicate balance between efficacy and safety. Traditionally centered on the maximum tolerated dose (MTD), contemporary therapies require a paradigm shift towards premarket dose optimization. Guided by Project … Continued
Authors: Professor Amin Rostami-Hodjegan, Professor Piet van der Graaf This Pharma Focus EU article, co-authored by Amin Rostami-Hodjegan, SVP of Research & Development and CSO at Certara, and Professor Piet van der Graaf, SVP and Head of QSP at Certara, explores the integration of artificial intelligence (AI) in drug discovery, focusing on quantitative systems pharmacology … Continued
Authors: Vijayalakshmi Chelliah, Piet H. van der Graaf One of the main areas where quantitative systems pharmacology (QSP) can impact drug discovery and development is target identification and validation. However, due to the multiscale nature and complexity of typical QSP models, the…
Authors: Ian E. Templeton, Karen Rowland-Yeo, Hannah M. Jones, Christopher J. Endres, Ariel R. Topletz-Erickson, Hao Sun, Anthony J. Lee A physiologically based pharmacokinetic (PBPK) model was developed to simulate plasma concentrations of tucatinib (Tukysa®) after single-dose or multiple-dose administration of 300 mg BID orally. This PBPK model was subsequently applied…
メディカルライティング | Volume 32, Issue 3 – Artificial Intelligence and Machine LearningAuthor: Anjana Bose AbstractApplications of artificial intelligence (AI)/machine learning (ML) components in drug development are growing exponentially. The trend is expected to continue. The growth has resulted in increased engagements on the part of regulatory agencies to ensure safe and effective use. This … Continued
Regulatory guidance paves the way to address ethical concerns in pediatric trials, and how additional strategies can be applied in drug evaluation.
Justin Hay, Senior Director, Amy Cheung Senior Director of Integrated Drug Development, and Patrick Loebs Director, at Certara, examine recent changes in paediatric guidelines and how they affect drug development projects.
Applied Clinical Trials-09-01-2023, Volume 32, Issue 9 Experts weigh in on the latest advances and adoption trends.
In this panel discussion, our panelists will explore how big data analytics is reshaping drug discovery, clinical trials, patient care, and regulatory decisions. Join us as we uncover the challenges, opportunities, and ethical dimensions of leveraging data to advance healthcare.
