Mind-blowing applications of QSP in drug development: Part 1
R&D World editors, Paul Heney and Aimee Kalnoskas, have their minds blown — multiple times!…
CertaraAugust 4, 2022
How Pharmaceutical Companies Can Engage Payers Digitally
Pharmaceutical companies should seize opportunities to digitally engage with payers globally using both face-to-face and…
CertaraJuly 29, 2022
How the Simcyp Discovery Simulator will Accelerate Early Drug Development
Physiologically-based pharmacokinetic (PBPK) modeling is a technique used to predict the absorption, distribution, metabolism, and…
CertaraJuly 19, 2022
Highlights from the FDA-ASCO Workshop on Dose Optimization for Oncology Drugs
The FDA-ASCO (American Society of Clinical Oncology) workshop on oncology dose optimization (3-5 May 2022)…
CertaraJuly 8, 2022
Why FDA’s New Guidance on Circulating Tumor DNA is Critical for Oncology Early Clinical Drug Development
2022 is shaping up to be the “year of the guidance” as the FDA has…
CertaraJuly 1, 2022
Reflections on the Recent ICH E11A Pediatric Extrapolation Guideline
The ICH E11A draft Guideline on Paediatric Extrapolation was released on 4 April 2022 entering a public…
CertaraJune 14, 2022
The Utility of Model-Informed Drug Development for Rare Diseases
Model-informed drug development (MIDD) is a network of closely integrated ecosystems that can seamlessly position…
CertaraMay 20, 2022
5 Reasons Why You Should Use Phoenix WinNonlin for PK/PD Analyses
Pharmaceutical companies around the globe face the challenge of increasingly longer drug development cycles and…
CertaraMarch 25, 2022
How to Fix Your Biggest Bioequivalence Mistakes
Bioequivalence is a commonly misunderstood term within biopharmaceutics. For starters, bioequivalence is a technical term…
CertaraMarch 16, 2022
New PMDA Validation Rules 3.0 Explained
In this blog, we explore what you need to know about the update to the…
CertaraMarch 2, 2022
