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Delivering High-Quality, Timely Responses to EMA Safety Queries Case Study Delivering High-Quality, Timely Responses to EMA Safety Queries A pharmaceutical company approached us for support with eight safety-related queries from the European Medicines…CertaraDecember 12, 2024
Static Versus Dynamic Model Predictions of Competitive Inhibitory Metabolic Drug–Drug Interactions via Cytochromes P450: One Step Forward and Two Steps Backwards Publication Static Versus Dynamic Model Predictions of Competitive Inhibitory Metabolic Drug–Drug Interactions via Cytochromes P450: One Step Forward and Two Steps Backwards Predicting metabolic drug–drug interactions (DDIs) via cytochrome P450 enzymes (CYP) is essential in drug development,…CertaraDecember 12, 2024
Preclinical data exposures underpredict clinical physiologically active doses for bispecific T-cell engagers in solid tumors indications; are there better metrics? -insights from a small mechanistic MBMA Poster Preclinical data exposures underpredict clinical physiologically active doses for bispecific T-cell engagers in solid tumors indications; are there better metrics? -insights from a small mechanistic MBMA CertaraDecember 11, 2024
CMC Writing Support Helps Client Lift Clinical Hold Case Study CMC Writing Support Helps Client Lift Clinical Hold In drug development, Chemistry, Manufacturing, and Controls (CMC) regulatory writing plays a pivotal role in ensuring the…CertaraDecember 10, 2024
Piet van der Graaf on AI and AI-assisted approaches in drug discovery & development Video Piet van der Graaf on AI and AI-assisted approaches in drug discovery & development At the 2024 AAPS PharmSci 360 conference, Bioanalysis Zone interviewed Piet van der Graaf, Senior…CertaraDecember 10, 2024
Advancing pharmacometrics in Africa – Transition from capacity development toward job creation Publication Advancing pharmacometrics in Africa – Transition from capacity development toward job creation This CPT article showcases, the Applied Pharmacometrics Training (APT) program, launched in 2021 by Pharmacometrics…CertaraDecember 9, 2024
Sneak Preview: Introducing TFL Studio On-Demand Webinar Sneak Preview: Introducing TFL Studio Get your preview of the upcoming Tables, Figures, and Listings (TFL) Module in Phoenix Cloud.…CertaraDecember 5, 2024
Key development considerations for cell therapies Blog Key development considerations for cell therapies December 5, 2024 What is a “cell therapy”? Nearly every recent oncology clinical conference has…CertaraDecember 5, 2024