The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA Publication The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA CertaraMarch 4, 2024
Guide to development of compound files for PBPK modeling in the Simcyp population-based simulator Publication Guide to development of compound files for PBPK modeling in the Simcyp population-based simulator The Simcyp Simulator is a software platform for population physiologically-based pharmacokinetic (PBPK) modeling and simulation.…CertaraFebruary 23, 2024
The interaction of core modules as a basis for elucidating network behavior determining Parkinson’s disease pathogenesis Publication The interaction of core modules as a basis for elucidating network behavior determining Parkinson’s disease pathogenesis It is well-established that misfolded alpha-synuclein (alpha-syn) is a histopathological marker of Parkinson's disease. Given…CertaraFebruary 14, 2024
Treatment patterns of patients with HR+/HER2- metastatic breast cancer receiving CDK4/6 inhibitor-based regimens: a cohort study in the French nationwide healthcare database Publication Treatment patterns of patients with HR+/HER2- metastatic breast cancer receiving CDK4/6 inhibitor-based regimens: a cohort study in the French nationwide healthcare database To assess real-world treatment patterns in patients diagnosed with hormone receptor positive (HR+), human epidermal…CertaraJanuary 17, 2024
Real-world application of PBPK in drug discovery Publication Real-world application of PBPK in drug discovery The utility of PBPK models in support of drug development has been well documented. During…CertaraJanuary 11, 2024
Physiologically Based Pharmacokinetic modelling of drugs in pregnancy: A mini-review on availability and limitations Publication Physiologically Based Pharmacokinetic modelling of drugs in pregnancy: A mini-review on availability and limitations This mini-review provides a concise and comprehensive overview of the pregnancy PBPK field and identify…CertaraJanuary 3, 2024
A Literature Review of Changes in Phase II Drug-Metabolizing Enzyme and Drug Transporter Expression during Pregnancy Publication A Literature Review of Changes in Phase II Drug-Metabolizing Enzyme and Drug Transporter Expression during Pregnancy This comprehensive review exposes gaps in current knowledge of phase II enzyme and drug transporter…CertaraJanuary 3, 2024
Total and Free Blood and Plasma Concentration Changes in Pregnancy for Medicines Highly Bound to Plasma Proteins: Application of Physiologically Based Pharmacokinetic Modelling to Understand the Impact on Efficacy Publication Total and Free Blood and Plasma Concentration Changes in Pregnancy for Medicines Highly Bound to Plasma Proteins: Application of Physiologically Based Pharmacokinetic Modelling to Understand the Impact on Efficacy For drugs highly bound to plasma proteins, changes in concentrations of free drug may have…CertaraJanuary 3, 2024
Incorporating Pragmatic Elements in Study Designs to Enhance Oncology Randomized Clinical Trials Publication Incorporating Pragmatic Elements in Study Designs to Enhance Oncology Randomized Clinical Trials A FRIENDS OF CANCER RESEARCH WHITE PAPER The article explores the complex landscape of determining…CertaraDecember 19, 2023
Model-informed target identification and validation through combining quantitative systems pharmacology with network-based analysis Publication Model-informed target identification and validation through combining quantitative systems pharmacology with network-based analysis Authors: Vijayalakshmi Chelliah, Piet H. van der Graaf One of the main areas where quantitative…CertaraNovember 28, 2023