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5 Steps to Satisfy New EU-CTR Requirements for Plain Language Summaries of Clinical Study Results

For the first time, the European Medicines Agency (EMA) has passed new regulations to help…

CertaraSeptember 27, 2022

Business transparency, integrity or data disclosure concept, businessman standing with disclosure financial document in crystal clear fish bowl

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EU-CTR Challenges Drug Developers Faced in the First 6 Months

Under European Union Clinical Trial Regulation 536/2014 (EU-CTR), replacing the EU Clinical Trial Directive (Directive…

CertaraSeptember 26, 2022

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3 Takeaways from the FDA Oligo Guidance You Need to Know

In June 2022, the FDA published their first oligonucleotide clinical pharmacology specific guidance . This…

CertaraSeptember 23, 2022

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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

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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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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

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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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How Pharmaceutical Companies Can Engage Payers Digitally

Pharmaceutical companies should seize opportunities to digitally engage with payers globally using both face-to-face and…

CertaraJuly 29, 2022

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How the Simcyp Discovery Simulator will Accelerate Early Drug Development

Physiologically-based pharmacokinetic (PBPK) modeling is a technique used to predict the absorption, distribution, metabolism, and…

CertaraJuly 19, 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

Blog

5 Steps to Satisfy New EU-CTR Requirements for Plain Language Summaries of Clinical Study Results

EU-CTR Challenges Drug Developers Faced in the First 6 Months

3 Takeaways from the FDA Oligo Guidance You Need to Know

3 Major Implications of New European Clinical Trial Regulations

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

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

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

How Pharmaceutical Companies Can Engage Payers Digitally

How the Simcyp Discovery Simulator will Accelerate Early Drug Development

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

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