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3 Major Implications of New European Clinical Trial Regulations

Have you heard the buzz around the new European Union Clinical Trial Regulations (EU-CTR) for…

CertaraAugust 25, 2022

Blog

Mind-blowing applications of QSP in drug development: Part 2

Part 2 of this blog series dives further into the June 2022 podcast with R&D…

CertaraAugust 15, 2022

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Stereochemistry in Compound Registration

Table of contents Flat bonds OR structure wedge types OR structure replicates Multiple OR labels…

CertaraAugust 14, 2022

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Why are Human Radiolabeled Mass-balance Studies Important in Clinical Pharmacology & Drug Development?

Human mass-balance studies are also called “C-14 studies” or “Absorption, Metabolism, and Excretion (AME) studies.”…

CertaraAugust 5, 2022

Blog

Mind-blowing applications of QSP in drug development: Part 1

R&D World editors, Paul Heney and Aimee Kalnoskas, have their minds blown — multiple times!…

CertaraAugust 4, 2022

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Highlights from the FDA-ASCO Workshop on Dose Optimization for Oncology Drugs

The FDA-ASCO (American Society of Clinical Oncology) workshop on oncology dose optimization (3-5 May 2022)…

CertaraJuly 8, 2022

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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

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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

Blog

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

Blog

3 Major Implications of New European Clinical Trial Regulations

Mind-blowing applications of QSP in drug development: Part 2

Stereochemistry in Compound Registration

Why are Human Radiolabeled Mass-balance Studies Important in Clinical Pharmacology & Drug Development?

Mind-blowing applications of QSP in drug development: Part 1

Highlights from the FDA-ASCO Workshop on Dose Optimization for Oncology Drugs

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

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