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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

Blog

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

Blog

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

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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

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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

Blog

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

Blog

Experts Unravel the Top 5 Myths Related to Bioequivalence

Bioequivalence enables bridging safety and effectiveness of oral pharmaceutical dosage forms using pharmacokinetics. The concepts…

CertaraFebruary 18, 2022

Blog

What is the FDA’s Project Optimus & How Will it Affect Oncology Drug Development?

Project Optimus is an initiative proposed by the U.S. Food and Drug Administration’s Oncology Center…

CertaraFebruary 2, 2022

Blog

Choosing an eCTD Submissions Vendor: Your Complete Checklist

Selecting the right electronic submission services vendor for your organization’s regulatory submissions to health authorities…

CertaraJanuary 28, 2022

Blog

Don’t Forget About Safety! How to Assess Drug Candidate Safety in Early Clinical Development

This blog will reflect on 3 things drug developers should pay attention to regarding safety…

CertaraJanuary 24, 2022

Blog

Why FDA’s New Guidance on Circulating Tumor DNA is Critical for Oncology Early Clinical Drug Development

Reflections on the Recent ICH E11A Pediatric Extrapolation Guideline

The Utility of Model-Informed Drug Development for Rare Diseases

5 Reasons Why You Should Use Phoenix WinNonlin for PK/PD Analyses

How to Fix Your Biggest Bioequivalence Mistakes

New PMDA Validation Rules 3.0 Explained

Experts Unravel the Top 5 Myths Related to Bioequivalence

What is the FDA’s Project Optimus & How Will it Affect Oncology Drug Development?

Choosing an eCTD Submissions Vendor: Your Complete Checklist

Don’t Forget About Safety! How to Assess Drug Candidate Safety in Early Clinical Development

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