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PBPK Modeling & Simulation of Therapeutic Oligonucleotides from Bench to Bedside

Next generation therapeutics Oligonucleotide drugs are unique among therapeutic modalities in that they don’t engage…

Certara2022年10月14日

Blog

The Growing Value of Quantitative Systems Pharmacology (QSP)

Gain a foundational understanding of QSP in this 101-level article with examples of QSP applied…

Certara2022年10月7日

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Choosing a Clinical Trial Transparency and Disclosure Vendor: Your Complete Checklist

Choosing the right technology and services vendor to support your organization’s transparency and disclosure (T&D)…

Certara2022年10月4日

Blog

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

Blog

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

Blog

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

ブログ

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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ブログ

PBPK Modeling & Simulation of Therapeutic Oligonucleotides from Bench to Bedside

The Growing Value of Quantitative Systems Pharmacology (QSP)

Choosing a Clinical Trial Transparency and Disclosure Vendor: Your Complete Checklist

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

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