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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…

Certara2025年7月1日

Blog

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

2025年6月30日 Drug development is increasingly defined by its complexity. Teams must navigate rising…

Certara2025年6月30日

Blog

Maintain & Adapt Pharma Market Access Digital Tools Using Feedback

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

Certara2025年6月30日

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…

Certara2025年6月27日

Blog

FDA ESG NextGen for Regulatory Submissions

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

Certara2025年6月25日

Blog

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

2025年6月16日 Editor’s note: This is the third of four articles in our series…

Simona Colucci2025年6月16日

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 -…

Certara2025年6月11日

ブログ

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…

Certara2025年6月9日

Blog

Systems modeling helps optimize safety and efficacy for oncolytic viruses

2025年5月30日 Gene therapies delivered in viral vectors offer an exciting and challenging approach…

Certara2025年5月30日

Blog

‘Most Favored Nation’ Policyが完全実施された際に世界の薬価に与える影響とは

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

Certara2025年5月23日

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ブログ

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

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が完全実施された際に世界の薬価に与える影響とは

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