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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

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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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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

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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

Redefining Regulatory Strategy with MIDD: Insights from the Draft ICH M15 Guidance

With the release of the draft ICH M15 guidance, MIDD is no longer optional -…

CertaraJune 11, 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

‘Most Favored Nation’ Policy Could Have Profound Impact on Global Drug Pricing if Fully Implemented

Editor’s Note: Jiwon Oh provided research support for this article. She is a Certara Market…

CertaraMay 23, 2025

Blog

CERTAINTY 2025: The power of Model-Informed Drug Development

We cover the key takeaways from CERTAINTY 2025, including the power of Model-Informed Drug Development…

CertaraMay 16, 2025

Blog

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

FDA ESG NextGen for Regulatory Submissions

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

Redefining Regulatory Strategy with MIDD: Insights from the Draft ICH M15 Guidance

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

Systems modeling helps optimize safety and efficacy for oncolytic viruses

‘Most Favored Nation’ Policy Could Have Profound Impact on Global Drug Pricing if Fully Implemented

CERTAINTY 2025: The power of Model-Informed Drug Development

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