How does a clinical development plan help drug programs?
How important is a clinical development plan? Your biotechnology start-up’s candidate asset has an intriguing…
Certara2024年7月26日
A guide to developing population files for physiologically-based pharmacokinetic modeling in the Simcyp Simulator
This collaborative effort by Certara and the Centre for Applied Pharmacokinetic Research (CAPKR) at The…
Certara2024年7月24日
A literature review of drug transport mechanisms during lactation
The literature review titled "A literature review of drug transport mechanisms during lactation," authored by…
Certara2024年7月7日
Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates
In recent years, oncology drug developers have invested in antibody-drug conjugates (ADCs). These targeted therapies…
Certara2024年5月10日
Everything You Need to Know About SDTM
Find out all you need to know about CDISC SDTM, from the SDTM implementation guide…
Certara2024年3月12日
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.…
Certara2024年2月23日
Interlaboratory Variability in the Madin–Darby Canine Kidney Cell Proteome
Madin–Darby canine kidney (MDCK) cells are widely used to study epithelial cell functionality. Their low…
Certara2023年6月28日
Blueprint for pandemic response: Focus on translational medicine, clinical pharmacology and pharmacometrics
Perhaps the most important lesson learned from the COVID‐19 pandemic is that of preparedness. Enhanced…
Certara2021年5月11日
Purity is a Virtue: A Practical Guide to the Reporting of Impurities
Many pharmaceutical companies struggle with characterizing drug substance (DS) and drug product (DP) impurities and…
Certara2021年3月23日
Optimize Immuno-oncology Drug Discovery and Development Using QSP
A Quantitative Systems Pharmacology (QSP) approach for developing combination immune-oncology therapies can be used to…
Certara2019年6月19日
