Drug Development Archives

Case Study

How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer

HUTCHMED was preparing a New Drug Application (NDA) submission for FRUZAQLA® (fruquintinib) a drug developed…

CertaraApril 7, 2026

Webinar

Earning Regulatory Trust: Practical Strategies to Increase Model Acceptance in MIDD

CertaraApril 6, 2026

Webinar

Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations

Danielle PillsburyApril 2, 2026

Publication

Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibitor Tuvusertib

This study demonstrates how a model-informed, totality-of-evidence approach was used to select the optimal clinical…

Danielle PillsburyApril 2, 2026

Infographic

6 ways Pinnacle 21 Enterprise centralized validation across studies

Learn how to centralize clinical data validation across studies using Pinnacle 21 Enterprise to improve…

CertaraApril 1, 2026

Blog

Data Fabrics in Pharma: Connecting Data for Better Decisions

Learn how a data fabric in pharma connects siloed systems. Explore the benefits of data…

CertaraMarch 31, 2026

Publication

Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics

This review article examines the development of radiopharmaceutical imaging agents and radioligand therapies for pediatric…

CertaraMarch 26, 2026

Publication

An Integrated Nonclinical and Clinical Risk Assessment of the Effects of Investigational ATRi Tuvusertib on QTc Interval in Patients With Solid Tumors

This publication highlights how pharmacometric modeling, supported by Certara, was used to inform dose selection…

CertaraMarch 25, 2026

On-Demand Webinar

Right Dose, Right Regimen: Model-Informed Strategies for Antibody–Drug Conjugates (ADCs)

Watch this on-demand webinar to learn how model-informed strategies using PopPK, PBPK, and QSP can…

CertaraMarch 25, 2026

Blog

Why the Most Important Phase 3 Decisions Should Be Made Before Phase 3

Learn how advanced modeling for reimbursement strategy using MBMA and QSP strengthens payer evidence and…

CertaraMarch 24, 2026

Drug Development

How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer

Earning Regulatory Trust: Practical Strategies to Increase Model Acceptance in MIDD

Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations

Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibitor Tuvusertib

6 ways Pinnacle 21 Enterprise centralized validation across studies

Data Fabrics in Pharma: Connecting Data for Better Decisions

Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics

An Integrated Nonclinical and Clinical Risk Assessment of the Effects of Investigational ATRi Tuvusertib on QTc Interval in Patients With Solid Tumors

Right Dose, Right Regimen: Model-Informed Strategies for Antibody–Drug Conjugates (ADCs)

Why the Most Important Phase 3 Decisions Should Be Made Before Phase 3

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