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The Reference-scaled Average Bioequivalence (RSABE) Approach

We examine the Reference-scaled Average Bioequivalence (RSABE) approach for generic drug development and how it…

CertaraJuly 1, 2025

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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

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Maintain & Adapt Pharma Market Access Digital Tools Using Feedback

Maintain the credibility of your pharma market access digital tools through continuous updates based on…

CertaraJune 30, 2025

Blog

The Do’s and Don’ts of Define.xml

Discover the 6 dos and don’ts of creating compliant define.xml files for FDA submission with…

CertaraJune 27, 2025

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Introducing the Project Progress Report – How to identify bottlenecks with Design Hub

Learn how to identify bottlenecks in your research process by utilizing the new project progress…

CertaraJune 27, 2025

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NMR Predictor Guide: Which Type Is Best for You?

Find out which type of NMR predictor may best serve your needs from this guide…

CertaraJune 26, 2025

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FDA ESG NextGen for Regulatory Submissions

The FDA ESG NextGen for Regulatory Submissions has replaced the FDA’s WebTrader and simplifies pharmaceutical…

CertaraJune 25, 2025

Blog

How a budget-impact analysis complements cost-effectiveness to present a balanced economic outlook

June 16, 2025 Editor’s note: This is the third of four articles in our series…

Simona ColucciJune 16, 2025

Blog

What are the most common in vitro drug-drug interaction study gaps?

Certara drug interaction science experts share data and experimental design gaps commonly found in in…

CertaraJune 9, 2025

Blog

Systems modeling helps optimize safety and efficacy for oncolytic viruses

May 30, 2025 Gene therapies delivered in viral vectors offer an exciting and challenging approach…

CertaraMay 30, 2025

Blog

The Reference-scaled Average Bioequivalence (RSABE) Approach

5 Clinical Development Challenges Model-Based Meta-Analysis (MBMA) Helps Address

Maintain & Adapt Pharma Market Access Digital Tools Using Feedback

The Do’s and Don’ts of Define.xml

Introducing the Project Progress Report – How to identify bottlenecks with Design Hub

NMR Predictor Guide: Which Type Is Best for You?

FDA ESG NextGen for Regulatory Submissions

How a budget-impact analysis complements cost-effectiveness to present a balanced economic outlook

What are the most common in vitro drug-drug interaction study gaps?

Systems modeling helps optimize safety and efficacy for oncolytic viruses

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