pre-update Archives

Press Coverage

Clinical Research News | Trendspotting: What’s Coming for Clinical Trials and Research in 2024

By Clinical Research Team We spoke with leaders and experts in the Clinical Research community…

CertaraJanuary 5, 2024

Press Coverage

Bio-IT World | Trendspotting: What’s Coming for Biotech in 2024

By Bio-IT World Team To kick off the New Year, we spoke with leaders and…

CertaraJanuary 5, 2024

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

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

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

On-Demand Webinar

Bridging the Gap: Integrating Pharmacometrics with Quantitative Systems Pharmacology (QSP) for Smoother Clinical Phase Transitions

Master clinical phase transitions with insights from industry leaders! Join Piet van der Graaf, SVP…

CertaraJanuary 2, 2024

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

On-Demand Webinar

Survival of the Fittest: Evolving Pharmacokinetic Modeling with Pirana

As regulatory acceptance of models for decision-making grows, so too does the need for optimally…

CertaraDecember 19, 2023

Blog

Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions

Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues…

CertaraDecember 12, 2023

Fact Sheet

Attain FDA Label Claims for Kinase Inhibitor Drugs with the Simcyp™ Simulator

Simcyp was used by pharma and biotech companies to inform, reduce and/or replace clinical studies…

CertaraDecember 6, 2023

pre-update

Clinical Research News | Trendspotting: What’s Coming for Clinical Trials and Research in 2024

Bio-IT World | Trendspotting: What’s Coming for Biotech in 2024

Physiologically Based Pharmacokinetic modelling of drugs in pregnancy: A mini-review on availability and limitations

A Literature Review of Changes in Phase II Drug-Metabolizing Enzyme and Drug Transporter Expression during Pregnancy

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

Bridging the Gap: Integrating Pharmacometrics with Quantitative Systems Pharmacology (QSP) for Smoother Clinical Phase Transitions

Incorporating Pragmatic Elements in Study Designs to Enhance Oncology Randomized Clinical Trials

Survival of the Fittest: Evolving Pharmacokinetic Modeling with Pirana

Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions

Attain FDA Label Claims for Kinase Inhibitor Drugs with the Simcyp™ Simulator

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