Publication

Pharmacokinetics, Safety Profile, and Tolerability of MN-08 Tablets after Single and Multiple Ascending Doses in Healthy Chinese Volunteers

Find out how Phase I study shows dose-related MN-08 exposure, 21–32 h half-life, and good…

CertaraFebruary 25, 2026

Webinar

Maximizing the Impact of Antibody–Drug Conjugates (ADCs): Model-Informed Labeling, Expansion, and Market Access

Danielle PillsburyFebruary 23, 2026

On-Demand Webinar

Start right, finish strong: Antibody-drug conjugate (ADC) studies for success

Learn how to build regulatory-ready first-in-human (FIH) dose strategies for antibody-drug conjugates (ADCs). Discover how…

CertaraFebruary 23, 2026

Blog

FAQs: The ICH M15 guideline and what it means for model-informed drug development

Learn what the ICH M15 guideline means for Model-Informed Drug Development, regulatory credibility, harmonization, and…

CertaraFebruary 18, 2026

Guide

Guided by Evidence: Implementing the ICH M15 Guideline for Model-Informed Drug Development (MIDD)

Prepare for ICH M15 guideline: Learn how to assess model credibility, align terminology, and strengthen…

CertaraFebruary 13, 2026

Blog

Pediatric drug development: From “wild west” to model-informed confidence

Model-informed drug development and precision dosing are transforming pediatric programs, from regulatory planning to Bayesian…

CertaraFebruary 11, 2026

Press Coverage

Why Many Global Drugs Never Reach Japan

Despite faster reviews, many global drugs never reach Japan. Learn how early development decisions, trial…

CertaraFebruary 5, 2026

Publication

Pharmacokinetic and toxicological evaluation of AB-CHMINACA in rodents: A comprehensive study

Explore how rodent study reveals 14 h half-life, key metabolites, and dose-dependent toxicity of AB-CHMINACA…

CertaraFebruary 5, 2026

Blog Knowledge Base

Trial designs: Non-inferiority vs. superiority vs. equivalence

Understand superiority, non-inferiority, and equivalence trials, how their hypotheses differ, and how trial design impacts…

Matt Zierhut, PhD MBAFebruary 3, 2026

Live Events

Phoenix Roadshow 2026 – Florence

CertaraFebruary 2, 2026

Clinical Pharmacology