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

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

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

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…

CertaraJuly 24, 2024

Conference

BioTechX Europe 2026

CertaraJuly 23, 2024

Blog

ICH M12 guidelines & your drug-drug interaction package

We have provided an overview of the key changes to the ICH M12 drug-drug interaction…

CertaraJune 19, 2024

Fact Sheet

Attain FDA Label Claims for Kinase Inhibitor Drugs with the Simcyp™ Simulator

Simcyp was used by pharma and biotech companies to inform, reduce and/or replace clinical studies…

CertaraDecember 6, 2023

Conference

American College of Toxicology 2026 Annual Meeting

– – Booth

CertaraMay 24, 2023

Conference

ACoP 2026

CertaraMay 24, 2023

Case Study

Using PBPK Models to Predict Effects of Hepatic Impairment & DDI in Olanzapine/Samidorphan Combination Therapy

Olanzapine is an effective antipsychotic medication used to treat schizophrenia, a disease that affects about…

CertaraOctober 31, 2022

Certara Products – Simcyp

PBPK Applications (MIFD) Using the Simcyp® Simulator

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

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

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

BioTechX Europe 2026

ICH M12 guidelines & your drug-drug interaction package

Attain FDA Label Claims for Kinase Inhibitor Drugs with the Simcyp™ Simulator

American College of Toxicology 2026 Annual Meeting

ACoP 2026

Using PBPK Models to Predict Effects of Hepatic Impairment & DDI in Olanzapine/Samidorphan Combination Therapy

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