Drug Development Archives

Publication

A tutorial on physiologically based pharmacokinetic approaches in lactation research

The tutorial by Amita Pansari, Xian Pan, Lisa M. Almond, and Karen Rowland-Yeo examines the…

Danielle Pillsbury2024年9月16日

Publication

Prediction of CYP-mediated DDIs involving inhibition: Approaches to address the requirements for system qualification of the Simcyp Simulator

The article "Prediction of CYP-mediated DDIs involving inhibition: Approaches to address the requirements for system…

Danielle Pillsbury2024年8月26日

Publication

Considerations for Physiologically Based Modeling in Liver Disease: From Nonalcoholic Fatty Liver (NAFL) to Nonalcoholic Steatohepatitis (NASH)

The article “Considerations for Physiologically Based Modeling in Liver Disease: From Nonalcoholic Fatty Liver (NAFL)…

Danielle Pillsbury2024年8月26日

ブログ

How does a clinical development plan help drug programs?

How important is a clinical development plan? Your biotechnology start-up’s candidate asset has an intriguing…

Certara2024年7月26日

Publication

A guide to developing population files for physiologically-based pharmacokinetic modeling in the Simcyp Simulator

This collaborative effort by Certara and the Centre for Applied Pharmacokinetic Research (CAPKR) at The…

Danielle Pillsbury2024年7月24日

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…

Danielle Pillsbury2024年7月7日

Blog

Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates

In recent years, oncology drug developers have invested in antibody-drug conjugates (ADCs). These targeted therapies…

Certara2024年5月10日

Blog

SDTMについて知っておくべきことすべて

Find out all you need to know about CDISC SDTM, from the SDTM implementation guide…

Certara2024年3月12日

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.…

Jim Gallagher2024年2月23日

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

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A tutorial on physiologically based pharmacokinetic approaches in lactation research

Prediction of CYP-mediated DDIs involving inhibition: Approaches to address the requirements for system qualification of the Simcyp Simulator

Considerations for Physiologically Based Modeling in Liver Disease: From Nonalcoholic Fatty Liver (NAFL) to Nonalcoholic Steatohepatitis (NASH)

How does a clinical development plan help drug programs?

A guide to developing population files for physiologically-based pharmacokinetic modeling in the Simcyp Simulator

A literature review of drug transport mechanisms during lactation

Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates

SDTMについて知っておくべきことすべて

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

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