Publication

From Prediction to Decision Making: PBPK and QSP as Regulatory-Grade NAMs

New CPT review by Certara's Karen Rowland Yeo & Piet van der Graaf shows how…

Danielle PillsburySeptember 23, 2026

Live Events

Tailwinds for MIDD: EMA, FDA, and a Converging Regulatory Landscape

October 29, 2026 - 11:00 PM – 2:00 PM

Chara LitouSeptember 9, 2026

Webinar

Application of PBPK Modeling Tools in Biopharmaceutics

Noriko Okudaira, PhDAugust 26, 2026

On-Demand Webinar

Beyond Trial and Error: Model-Informed Formulation Development in Practice

Learn how model-informed formulation development and PBPK modeling can guide formulation strategy, bioequivalence, and biowaiver…

Siri Kalyan ChirumamillaAugust 24, 2026

Live Events

Tailwinds for MIDD: What to Know About the Changing Regulatory Landscape

September 30, 2026 - 11:30 PM – 2:00 PM

CertaraAugust 12, 2026

Poster

Assessing Cross-Version Simcyp Simulator Prediction Performance Using a Bioequivalence Framework to Support EMA Qualification

See how Simcyp Simulator V20–V24 DDI predictions were shown equivalent to the EMA-qualified V19 using…

CertaraJuly 24, 2026

Blog

When to conduct hepatic impairment studies and when modeling may be enough

How to decide if a hepatic impairment study is required, choose the right study design,…

Zoe BarterJuly 13, 2026

On-Demand Webinar

Integrated mechanistic modeling approaches in oncology drug development

Learn how integrated QSP and PBPK modeling supports dose justification, patient stratification, and regulatory decisions…

CertaraJuly 8, 2026

Poster

PBPK Modeling in Lieu of Clinical Endpoint Bioequivalence Study for Generic Tazarotene Cream 0.05%

Learn how Simcyp PBPK modeling established bioequivalence and supported FDA approval of a generic product

CertaraJuly 1, 2026

On-Demand Webinar

The Power of Modeling: Speed, Early De-Risking, and Regulatory Success for Forward-Thinking Sponsors

Learn how PBPK and QSP modeling support faster drug development by enabling smarter dose selection,…

CertaraJuly 1, 2026

Certara Products – Simcyp

From Prediction to Decision Making: PBPK and QSP as Regulatory-Grade NAMs

Tailwinds for MIDD: EMA, FDA, and a Converging Regulatory Landscape

Application of PBPK Modeling Tools in Biopharmaceutics

Beyond Trial and Error: Model-Informed Formulation Development in Practice

Tailwinds for MIDD: What to Know About the Changing Regulatory Landscape

Assessing Cross-Version Simcyp Simulator Prediction Performance Using a Bioequivalence Framework to Support EMA Qualification

When to conduct hepatic impairment studies and when modeling may be enough

Integrated mechanistic modeling approaches in oncology drug development

PBPK Modeling in Lieu of Clinical Endpoint Bioequivalence Study for Generic Tazarotene Cream 0.05%

The Power of Modeling: Speed, Early De-Risking, and Regulatory Success for Forward-Thinking Sponsors

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