Publication

Evaluation of a New Formulation That Improves the Bioavailability and Food Effect of Abiraterone: An Open-Label, Crossover, Randomized, Controlled, Phase I Clinical Trial

Find out how RL001 delivers >1000 mg tablet exposure with reduced food effect and improved…

CertaraJanuary 1, 2026

Publication

Pharmacokinetics, Bioequivalence, and Safety of Diclofenac Sodium Sustained-Release Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions

Explore how two replicated trials confirm diclofenac SR test and reference tablets are bioequivalent under…

CertaraJanuary 1, 2026

Blog

Delivering on deadline: Why pharmacometrics (pmx) is the anchor of successful regulatory submissions

Explore how PMx regulatory submissions, exposure-response modeling, and strategic pharmacometrics planning support successful and timely…

CertaraDecember 29, 2025

Fact Sheet

Strategic Project Management for Accelerated Drug Development

Expert project leadership to keep complex programs on track, aligned, and moving forward—so you can…

CertaraDecember 23, 2025

Press Coverage

Pharma positions itself for 2026 amid an evolving US landscape

Explore how U.S. policy changes — including tariffs, onshoring, and Most Favored Nation pricing —…

CertaraDecember 22, 2025

Conference

International PBPK Conference

certarastgDecember 22, 2025

Conference

MVA Oncology Network

CertaraDecember 19, 2025

Publication

A Systematic Review and Model-Based Meta-Analysis of Pegylated-Interferon-α-Induced HBsAg Loss in Chronic Hepatitis B Virus Infection

This study synthesizes data from a large body of clinical trials to evaluate rates of…

CertaraDecember 18, 2025

Publication

A Tutorial on the Development of a Physiologically Inspired PKRO Model for Monoclonal Antibodies

This tutorial introduces the physiologically inspired PKRO (piPKRO) model - a streamlined, mechanistic framework for…

CertaraDecember 18, 2025

Poster

First-in-human dosing model for MDX2004, a novel trispecific CD3xCD28/4-1BB antibody-fusion protein for advanced malignancies

Learn how QSP modeling enabled safe, data-driven FIH dose prediction for the trispecific T-cell activator…

CertaraDecember 16, 2025

Evaluation of a New Formulation That Improves the Bioavailability and Food Effect of Abiraterone: An Open-Label, Crossover, Randomized, Controlled, Phase I Clinical Trial

Pharmacokinetics, Bioequivalence, and Safety of Diclofenac Sodium Sustained-Release Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions

Delivering on deadline: Why pharmacometrics (pmx) is the anchor of successful regulatory submissions

Strategic Project Management for Accelerated Drug Development

Pharma positions itself for 2026 amid an evolving US landscape

International PBPK Conference

MVA Oncology Network

A Systematic Review and Model-Based Meta-Analysis of Pegylated-Interferon-α-Induced HBsAg Loss in Chronic Hepatitis B Virus Infection

A Tutorial on the Development of a Physiologically Inspired PKRO Model for Monoclonal Antibodies

First-in-human dosing model for MDX2004, a novel trispecific CD3xCD28/4-1BB antibody-fusion protein for advanced malignancies

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