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抗体薬物複合体開発の成功の確率を最大化するための主な検討事項

Antibody drug conjugates (ADC) are a unique way to obliterate tumor cells and represent an…

Certara2021年7月8日

Blog

Maximizing Oligonucleotide Therapeutic Development: Pre-clinical and Translational Considerations

This is the second of three blog posts discussing best practices for developing oligonucleotide therapeutics.…

Certara2021年6月25日

Blog

Simcyp PBPK Simulatorをお客様の医薬品開発プログラムに統合する10のメリット

Per US FDA’s recent paper on the topic, Physiologically based Pharmacokinetic (PBPK) modeling & simulation…

Certara2021年6月22日

Blog

Preparing for High Stakes Meetings; How to Best Convey a New Drug’s Value to Payers

This blog post includes key takeaways from the opening session of Certara’s first Strategic Evidence…

Certara2021年6月18日

Blog

Watershed Moment for the Future of Cell Therapy Development – FDA Advisory Committee Meeting

Every FDA Advisory Committee meeting is unique, and the Cellular, Tissue, and Gene Therapies Advisory…

Certara2021年6月15日

Blog

Why Your Regulatory Writers Need eCTD Authoring Templates

If you’ve heard about eCTD authoring template suites before, but you’re not sure what they…

Certara2021年5月14日

Blog

Maximizing Oligonucleotide Therapeutic Development: How They Work

This is the first of three blog posts discussing best practices for developing oligonucleotides. Interest…

Certara2021年5月7日

Blog

Planning a Health Canada PRCI Compliant Submission

How to set yourself up for a successful Health Canada PRCI submission

Certara2021年4月26日

Blog

Simcyp Simulator Impacts 80+ Novel Drugs

250 Label claims using PBPK without the need for additional clinical studies “Clinical Studies and…

Certara2021年3月17日

Blog

The Importance of Continuity of Operations Plans for Gene Therapy Manufacturers

By: James Zoshak The COVID-19 pandemic has added increased risk and uncertainty to gene therapy…

Certara2021年2月22日

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抗体薬物複合体開発の成功の確率を最大化するための主な検討事項

Maximizing Oligonucleotide Therapeutic Development: Pre-clinical and Translational Considerations

Simcyp PBPK Simulatorをお客様の医薬品開発プログラムに統合する10のメリット

Preparing for High Stakes Meetings; How to Best Convey a New Drug’s Value to Payers

Watershed Moment for the Future of Cell Therapy Development – FDA Advisory Committee Meeting

Why Your Regulatory Writers Need eCTD Authoring Templates

Maximizing Oligonucleotide Therapeutic Development: How They Work

Planning a Health Canada PRCI Compliant Submission

Simcyp Simulator Impacts 80+ Novel Drugs

The Importance of Continuity of Operations Plans for Gene Therapy Manufacturers

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