Model Informed Drug Development Archives

Publication

A literature review of drug transport mechanisms during lactation

The literature review titled "A literature review of drug transport mechanisms during lactation," authored by…

CertaraJuly 7, 2024

Blog

Why Medical/Regulatory Writing Services Use Style Guides & Lexicons

Learn how style guides and lexicons help medical writers produce clear, consistent, and accurate content…

CertaraMarch 18, 2024

Publication

Guide to development of compound files for PBPK modeling in the Simcyp population-based simulator

The Simcyp Simulator is a software platform for population physiologically-based pharmacokinetic (PBPK) modeling and simulation.…

CertaraFebruary 23, 2024

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…

CertaraJune 28, 2023

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…

CertaraJune 14, 2023

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,…

CertaraSeptember 23, 2021

Press Coverage

How New FDA Guidance Project Optimus May Affect Future of Oncology Clinical Trials, Drug Pipeline

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

CertaraAugust 16, 2021

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…

CertaraAugust 13, 2021

Case Study

Simcyp Simulator Demonstrates Bioequivalence (BE), Eliminating Need for Costly Clinical Study

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

CertaraJuly 29, 2021

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.…

CertaraJune 25, 2021

Model Informed Drug Development

A literature review of drug transport mechanisms during lactation

Why Medical/Regulatory Writing Services Use Style Guides & Lexicons

Guide to development of compound files for PBPK modeling in the Simcyp population-based simulator

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

How New FDA Guidance Project Optimus May Affect Future of Oncology Clinical Trials, Drug Pipeline

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

Simcyp Simulator Demonstrates Bioequivalence (BE), Eliminating Need for Costly Clinical Study

Maximizing Oligonucleotide Therapeutic Development: Pre-clinical and Translational Considerations

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