Drug Development Archives

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…

CertaraMay 10, 2024

Blog

Everything You Need to Know About SDTM

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

CertaraMarch 12, 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

Conference

American College of Toxicology 2025 Annual Meeting

– – Booth

CertaraMay 24, 2023

Conference

ACoP 2025

CertaraMay 24, 2023

Conference

ACCP Annual Meeting

– – Booth

CertaraJuly 15, 2022

Publication

Blueprint for pandemic response: Focus on translational medicine, clinical pharmacology and pharmacometrics

Perhaps the most important lesson learned from the COVID‐19 pandemic is that of preparedness. Enhanced…

CertaraMay 11, 2021

On-Demand Webinar

Purity is a Virtue: A Practical Guide to the Reporting of Impurities

Many pharmaceutical companies struggle with characterizing drug substance (DS) and drug product (DP) impurities and…

CertaraMarch 23, 2021

White Paper

Optimize Immuno-oncology Drug Discovery and Development Using QSP

A Quantitative Systems Pharmacology (QSP) approach for developing combination immune-oncology therapies can be used to…

CertaraJune 19, 2019

Drug Development

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

Everything You Need to Know About SDTM

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

American College of Toxicology 2025 Annual Meeting

ACoP 2025

ACCP Annual Meeting

Blueprint for pandemic response: Focus on translational medicine, clinical pharmacology and pharmacometrics

Purity is a Virtue: A Practical Guide to the Reporting of Impurities

Optimize Immuno-oncology Drug Discovery and Development Using QSP

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