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

全新 FDA 指南 Project Optimus 可能如何影响肿瘤学临床试验和药物研究计划的未来

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

Jim Gallagher2021 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…

Rajesh Krishna and David Gutstein2021 年 8 月 13 日

Case Study

Simcyp™ Simulator 证明了生物等效性 (BE)，无需进行昂贵的临床研究

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.…

Martin Beliveau2021 年 6 月 25 日

Brochure

推动具有影响力的科学成果从实验室走向市场

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…

Jim Gallagher2021 年 6 月 1 日

网络研讨会点播

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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模型引导的药物开发

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

全新 FDA 指南 Project Optimus 可能如何影响肿瘤学临床试验和药物研究计划的未来

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

Simcyp™ Simulator 证明了生物等效性 (BE)，无需进行昂贵的临床研究

Maximizing Oligonucleotide Therapeutic Development: Pre-clinical and Translational Considerations

推动具有影响力的科学成果从实验室走向市场

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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