Publication

Population Pharmacokinetic Analyses and Exposure-Efficacy Relationships of Venetoclax in Chinese Pediatric Patients with Hematological Malignancy in a Real-World Setting

Find out how PopPK model links higher venetoclax exposure to MRD-negative status in pediatric AML…

CertaraMarch 20, 2026

Blog

ICH M15 guideline: What the finalized guideline means for model-informed drug development

With the release of the draft ICH M15 guidance, MIDD is no longer optional -…

CertaraMarch 18, 2026

Publication

Creatinine- and cystatin C-based population pharmacokinetic models for predicting mycophenolic acid clearance in patients with autoimmune diseases

Explore how creatinine-based equations best predict MPA clearance in autoimmune disease patients in a Phoenix…

CertaraMarch 18, 2026

Publication

Pharmacokinetics and Bioequivalence of Propafenone Hydrochloride Tablets under Fasting Conditions in Healthy Subjects

Discover how replicated crossover study shows propafenone formulations meet bioequivalence criteria despite high within-subject variability.

CertaraMarch 18, 2026

Blog

Advancing pharmacoequity through model-informed drug development: Insights from ASCPT 2026

Explore how model-informed drug development and AI are advancing pharmacoequity and shaping the future of…

CertaraMarch 11, 2026

Publication

Model-Based Meta-Analysis of Objective Response Rate and Survival Endpoints to Compare PD-1 and PD-L1 Treatment Outcomes in Non-Small Cell Lung Cancer

This study used model-based meta-analysis (MBMA) to assess how well objective response rate (ORR) predicts…

Danielle PillsburyMarch 4, 2026

Blog

ADC first-in-human (FIH) dose selection: Designing FIH studies for success

Optimize ADC First-in-Human Dose Selection with model-informed strategies and exposure–response insights to design safer, more…

CertaraMarch 3, 2026

Conference

Apotekarsocieteten Clinical Pharmacology Strategies in Drug Development

Danielle PillsburyMarch 2, 2026

Publication

Pharmacokinetic Characterization and Bioequivalence of Sildenafil Citrate Orally Disintegrating Tablets in Healthy Volunteers

Learn how orally disintegrating sildenafil tablets are bioequivalent to reference formulation in fasting volunteers using…

CertaraMarch 1, 2026

Blog

Embracing model-informed drug discovery: The path to better clinical outcomes

We cover the evidence of biosimulation improving clinical success rates, making the case for model-informed…

CertaraFebruary 27, 2026

Modeling and Simulation

Population Pharmacokinetic Analyses and Exposure-Efficacy Relationships of Venetoclax in Chinese Pediatric Patients with Hematological Malignancy in a Real-World Setting

ICH M15 guideline: What the finalized guideline means for model-informed drug development

Creatinine- and cystatin C-based population pharmacokinetic models for predicting mycophenolic acid clearance in patients with autoimmune diseases

Pharmacokinetics and Bioequivalence of Propafenone Hydrochloride Tablets under Fasting Conditions in Healthy Subjects

Advancing pharmacoequity through model-informed drug development: Insights from ASCPT 2026

Model-Based Meta-Analysis of Objective Response Rate and Survival Endpoints to Compare PD-1 and PD-L1 Treatment Outcomes in Non-Small Cell Lung Cancer

ADC first-in-human (FIH) dose selection: Designing FIH studies for success

Apotekarsocieteten Clinical Pharmacology Strategies in Drug Development

Pharmacokinetic Characterization and Bioequivalence of Sildenafil Citrate Orally Disintegrating Tablets in Healthy Volunteers

Embracing model-informed drug discovery: The path to better clinical outcomes

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