Model Informed Drug Development Archives

Publication

Interlaboratory Variability in the Madin–Darby Canine Kidney Cell Proteome

Madin–Darby canine kidney (MDCK) cells are widely used to study epithelial cell functionality. Their low…

Danielle Pillsbury2023年6月28日

Publication

Model-Informed Approaches and Innovative Clinical Trial Design for Adeno-Associated Viral Vector-Based Gene Therapy Product Development: A White Paper

The promise of viral vector-based gene therapy (GT) as a transformative paradigm for treating severely…

Danielle Pillsbury2023年6月14日

Publication

Drug repurposing: Misconceptions, challenges, and opportunities for academic researchers

Drug repurposing is promoted as a cost- and time-effective mechanism for providing new medicines. Often,…

Craig Rayner2021年9月23日

Article

新しい米国FDAガイダンスのプロジェクト・オプティマスが、オンコロジー臨床試験、医薬品パイプラインの今後に及ぼす可能性のある影響について

Julie Bullock, VP, global head of clinical pharmacology and translational medicine at Certara, discusses the…

Certara2021年8月16日

Blog

Gene Therapy Based Precision Medicine Therapeutics: Clinical Pharmacology & Translational Science Considerations

The era of gene therapy may have started a couple of decades ago, but approvals…

Certara2021年8月13日

Case Study

Simcypシミュレーターにより生物学的同等性（BE）を実証し、高額な臨床試験が不要に

In this case study, the sponsor’s closing of a manufacturing site required that one of…

Jim Gallagher2021年7月29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

Brochure

ベンチから市場へ、インパクトのあるサイエンスを推進

Learn how Certara drives impactful science.

Jim Gallagher2021年6月14日

Video

Your First Choice in Complex Biologics Drug Development

The pharmaceutical has made massive investments in complex biologics, a drug class that includes oligonucleotide…

Certara2021年6月1日

オンデマンド・ウェビナー

The Wizard of Oligos: There’s no place like having a successful drug development program!

Oligonucleotide therapies— nucleic acid polymers with the potential to treat or manage a wide range…

Jim Gallagher2021年4月30日

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モデルに基づく医薬品開発

Interlaboratory Variability in the Madin–Darby Canine Kidney Cell Proteome

Model-Informed Approaches and Innovative Clinical Trial Design for Adeno-Associated Viral Vector-Based Gene Therapy Product Development: A White Paper

Drug repurposing: Misconceptions, challenges, and opportunities for academic researchers

新しい米国FDAガイダンスのプロジェクト・オプティマスが、オンコロジー臨床試験、医薬品パイプラインの今後に及ぼす可能性のある影響について

Gene Therapy Based Precision Medicine Therapeutics: Clinical Pharmacology & Translational Science Considerations

Simcypシミュレーターにより生物学的同等性（BE）を実証し、高額な臨床試験が不要に

Maximizing Oligonucleotide Therapeutic Development: Pre-clinical and Translational Considerations

ベンチから市場へ、インパクトのあるサイエンスを推進

Your First Choice in Complex Biologics Drug Development

The Wizard of Oligos: There’s no place like having a successful drug development program!

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