Pirana Tips and Tricks – Report Object Generation in Pirana Blog Post
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The Reference-scaled Average Bioequivalence (RSABE) Approach Blog Post
We examine the Reference-scaled Average Bioequivalence (RSABE) approach for generic drug development and how it compares with the standard approach.
5 Clinical Development Challenges Model-Based Meta-Analysis (MBMA) Helps Address Blog Post
Erika Brooks June 30, 2025 Drug development is increasingly defined by its complexity. Teams must navigate rising costs, tighter regulatory scrutiny, and growing pressure to deliver therapies faster—often with limited...
Maintain & Adapt Pharma Market Access Digital Tools Using Feedback Blog Post
Maintain the credibility of your pharma market access digital tools through continuous updates based on user feedback. Learn more…
The Do’s and Don’ts of Define.xml Blog Post
Discover the 6 dos and don’ts of creating compliant define.xml files for FDA submission with our free, downloadable Define-XML format guide.
How Model-informed drug development rescue projects from a risky situation Blog Post
Discover how Certara’s integrated approach to model-informed drug development helps clients navigate regulatory challenges, achieve key milestones, and ensure commercial success with over 700 experts worldwide.
Increasing Productivity In Pharma R&D Starts With Data Blog Post
Publication: Forbes Technology Council Abstract This article discusses the growing volume of raw data collected during clinical research, and how transforming the mountain of data into clinical and safety insights...
FDA ESG NextGen for Regulatory Submissions Blog Post
The FDA ESG NextGen for Regulatory Submissions has replaced the FDA’s WebTrader and simplifies pharmaceutical registration and submission management.
Applications of an Immunogenicity QSP Platform: Predictive Modelling for ADA and PK Impact for Biotherapeutic Combinations Blog Post
Learn how a QSP platform predicts ADA and PK effects in combo immunotherapies like nivolumab + ipilimumab using mechanistic modeling.
