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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…

Certara2022年9月26日

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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…

Certara2022年9月23日

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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…

Certara2022年8月25日

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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…

Certara2022年8月15日

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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.”…

Certara2022年8月5日

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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!…

Certara2022年8月4日

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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…

Certara2022年7月29日

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Simcypディスカバリーシミュレーターが早期の医薬品開発を加速する方法

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

Certara2022年7月19日

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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)…

Certara2022年7月8日

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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…

Certara2022年7月1日

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ブログ

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

Simcypディスカバリーシミュレーターが早期の医薬品開発を加速する方法

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

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