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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…

Certara2022年9月27日

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…

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

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…

Certara2022年8月15日

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臨床薬理学および医薬品開発において、ヒトの放射性標識マスバランス試験が重要な理由

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

Certara2022年8月5日

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!…

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

Blog

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

Blog

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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ブログ

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

臨床薬理学および医薬品開発において、ヒトの放射性標識マスバランス試験が重要な理由

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

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