Publication

Optimization of voriconazole dosage via population pharmacokinetic analysis based on the albumin-bilirubin (ALBI) score of patients with liver dysfunction

See how ALBI‑based PopPK modelling supports practical voriconazole dose reductions in liver dysfunction using Phoenix…

CertaraJuly 2, 2025

Press Coverage

The Medicine Maker: The Biosimulation Generation

The article, The Biosimulation Generation, explores the transformative potential of biosimulation in pharmaceutical R&D as…

Danielle PillsburyJuly 1, 2025

Publication

Bioequivalence study of two formulations of lurasidone film coated tablets in healthy subjects under fed conditions

Learn how fed‑condition crossover study confirms lurasidone bioequivalence and comparable safety using Phoenix WinNonlin.

CertaraJuly 1, 2025

Publication

Impact of body weight on mycophenolic acid population pharmacokinetics in paediatric lupus nephritis: a pharmacogenomic integration study

Find out how PopPK modelling shows body weight is the key driver of MPA exposure…

CertaraJuly 1, 2025

Blog

5 clinical development challenges model-based meta-analysis (MBMA) helps address

June 30, 2025 Drug development is increasingly defined by its complexity. Teams must navigate rising…

CertaraJune 30, 2025

Case Study

How Model-informed drug development rescue projects from a risky situation

Discover how Certara’s integrated approach to model-informed drug development helps clients navigate regulatory challenges, achieve…

CertaraJune 26, 2025

Publication

Critical Roles for Modeling and Simulation and Real-World Evidence to Inform Challenges in Clinical Trial Diversity Planning

Due to the highly controlled settings of clinical trials, enrolled subjects may not be fully…

CertaraJune 19, 2025

Publication

In Vivo PK-PD and Drug-Drug Interaction Study of Dorzagliatin for the Management of PI3Kα Inhibitor-Induced Hyperglycemia

Explore how dorzagliatin increases exposure and improves antitumor efficacy when combined with PI3Kα inhibitors, analysed…

CertaraJune 19, 2025

On-Demand Webinar

From Data to Decisions: Real-World Impact of Model-Based Meta-Analysis (MBMA) with GSK and Certara

Discover the Real-World Impact of Model-Based Meta-Analysis. Hear from experts, see case studies to advance…

CertaraJune 18, 2025

Publication

Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer

The study, published in the Journal of Clinical Pharmacology, evaluates the cardiac safety of fruquintinib,…

CertaraJune 8, 2025

Modeling and Simulation

Optimization of voriconazole dosage via population pharmacokinetic analysis based on the albumin-bilirubin (ALBI) score of patients with liver dysfunction

The Medicine Maker: The Biosimulation Generation

Bioequivalence study of two formulations of lurasidone film coated tablets in healthy subjects under fed conditions

Impact of body weight on mycophenolic acid population pharmacokinetics in paediatric lupus nephritis: a pharmacogenomic integration study

5 clinical development challenges model-based meta-analysis (MBMA) helps address

How Model-informed drug development rescue projects from a risky situation

Critical Roles for Modeling and Simulation and Real-World Evidence to Inform Challenges in Clinical Trial Diversity Planning

In Vivo PK-PD and Drug-Drug Interaction Study of Dorzagliatin for the Management of PI3Kα Inhibitor-Induced Hyperglycemia

From Data to Decisions: Real-World Impact of Model-Based Meta-Analysis (MBMA) with GSK and Certara

Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer

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