Publication

Enhanced Bioavailability of a Novel Oil-Based Lutein Formulation: A Randomized, Double-Blind, Single-Dose, Comparative Oral Bioavailability Study in Healthy Adults

See how a randomized, double-blind study proved enhanced bioavailability of a novel oil-based lutein formulation,…

CertaraJuly 14, 2026

On-Demand Webinar

Global Health Policy on the Move: Impact of MFN and EU HTA reform on Global and Regional Access

CertaraJuly 13, 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

Conference

ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop

Matt Zierhut, PhD MBAJuly 9, 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

Blog

AI, HTA, and the future of access: Inside the 12th annual Kraków HTA symposium

Explore key insights from the 12th Annual Kraków HTA Symposium covering HTA, reimbursement policy, AI…

Malwina Holownia, PhDJuly 8, 2026

Blog

Dosimetry for radiopharmaceutical therapy: From measurement to dose justification

Why dosimetry for radiopharmaceutical therapy needs more than absorbed dose. How BED, radiation dosimetry &…

Hunter Stephens, PhDJuly 7, 2026

eBook

Recommendations for Adopting New Approach Methodologies to Reduce Animal Testing in Drug Development

Discover advanced regulatory writing strategies, global regulatory submission best practices, eCTD guidance, ICH M15 updates…

CertaraJuly 7, 2026

Publication

Population PK Modeling Supporting the Aripiprazole Two-Injection Start Regimen in Japanese Patients

Learn how population PK modeling and simulation supported a regulatory strategy for a simplified aripiprazole…

Danielle PillsburyJuly 7, 2026

Blog

Cracking the code on NCA: How Pinnacle 21 helps de-risk PK analyses

Learn how Pinnacle 21, strong data foundations, and better workflows reduce risk in PK noncompartmental…

Wendy YoungJuly 7, 2026

Enhanced Bioavailability of a Novel Oil-Based Lutein Formulation: A Randomized, Double-Blind, Single-Dose, Comparative Oral Bioavailability Study in Healthy Adults

Global Health Policy on the Move: Impact of MFN and EU HTA reform on Global and Regional Access

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

ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop

Integrated mechanistic modeling approaches in oncology drug development

AI, HTA, and the future of access: Inside the 12th annual Kraków HTA symposium

Dosimetry for radiopharmaceutical therapy: From measurement to dose justification

Recommendations for Adopting New Approach Methodologies to Reduce Animal Testing in Drug Development

Population PK Modeling Supporting the Aripiprazole Two-Injection Start Regimen in Japanese Patients

Cracking the code on NCA: How Pinnacle 21 helps de-risk PK analyses

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