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eBook

Waiving clinical studies & accelerating drug development for kinase inhibitor drugs

Whether you're in pre, early, or late clinical stages, this eBook offers real-world insights into…

CertaraAugust 28, 2024

eBook

PBPK Applications (MIFD) Using the Simcyp® Simulator

Explores strategies, regulatory validation, and solutions in small-molecule human Physiologically Based Pharmacokinetic modeling (PBPK).

CertaraAugust 28, 2024

Guide

Certara’s Integrated, Compliant Clinical Data Solution From Trial to Regulatory Submission

Click on any of the steps below to learn more.

CertaraAugust 28, 2024

Case Study

Asciminib – PBPK Modeling Streamlines Development and Avoids Over 10 Clinical Trials

Asciminib (Scemblix®) is a novel drug with a unique mechanism of action for treating CML.…

CertaraAugust 27, 2024

Conference

DMDG in vivo ADME one-day meeting 2024

CertaraAugust 27, 2024

Blog

How has the Inflation Reduction Act Impacted the Biosimilars Market?

The Inflation Reduction Act (IRA), one of the key legislative achievements the Biden-Harris administration, aims…

CertaraAugust 27, 2024

Fact Sheet

Phoenix™ NLME

CertaraAugust 26, 2024

Fact Sheet

Phoenix™ PK/PD Platform Overview

CertaraAugust 26, 2024

Press Coverage

FDA’s Lykos Rejection Delays—But Doesn’t Stop—Psychedelic Therapies

Certara's Dr. Fran Brown, Senior Vice President of Drug Development Science, is quoted in this…

CertaraAugust 26, 2024

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…

CertaraAugust 26, 2024

Waiving clinical studies & accelerating drug development for kinase inhibitor drugs

PBPK Applications (MIFD) Using the Simcyp® Simulator

Certara’s Integrated, Compliant Clinical Data Solution From Trial to Regulatory Submission

Asciminib – PBPK Modeling Streamlines Development and Avoids Over 10 Clinical Trials

DMDG in vivo ADME one-day meeting 2024

How has the Inflation Reduction Act Impacted the Biosimilars Market?

Phoenix™ NLME

Phoenix™ PK/PD Platform Overview

FDA’s Lykos Rejection Delays—But Doesn’t Stop—Psychedelic Therapies

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

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