On-Demand Webinar

BioSpace webinar: Streamlining Nonclinical Development with FDA NAMs

Learn how to apply FDA NAM guidance to streamline nonclinical development, support IND decisions, and…

Certara2026 年 5 月 8 日

Guide

Designing Drug Development Programs for Reimbursement Success

Download the guide to learn how model-informed drug development, QSP, and MBMA help align with…

Certara2026 年 5 月 7 日

Publication

Population Pharmacodynamic Modeling of Plozasiran for Treatment of Familial Chylomicronemia Syndrome

A newly approved RNA interference (RNAi) therapy lowers harmful triglyceride (TG) levels in patients with…

Certara2026 年 5 月 7 日

Publication

Population Pharmacokinetics and Exposure-Response Analysis of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1 Mutation

This study evaluated how the leukemia drug ziftomenib behaves in the body and whether different…

Certara2026 年 5 月 7 日

Publication

Population Pharmacokinetic Modeling and Exposure-Response Analyses of Nemtabrutinib in Patients With Hematologic Malignancies

Population pharmacokinetic (PopPK) and exposure-response modeling were used to support the clinical development of nemtabrutinib,…

Certara2026 年 5 月 7 日

Press Coverage

The one-trial era: what the FDA’s shift signals for the future of drug development

The FDA is shifting toward approving drugs based on a single pivotal trial supported by…

Certara2026 年 5 月 6 日

Blog

Optimize readiness for MHRA-NICE aligned pathway

Achieve HTA and regulatory success in the MHRA–NICE pathway through early evidence alignment.

Certara2026 年 5 月 1 日

Blog Knowledge Base

Understanding LC/MS/MS

Discover LC/MS/MS applications in therapy development and bioanalytical method development for robust, compliant pharmaceutical research.

Deven Shah, BPharm, PhD2026 年 5 月 1 日

Video

Certara Talks – Pivotal Trial Mandate

Explore how the FDA’s shift toward one pivotal trial plus supporting evidence could reshape drug…

Certara2026 年 4 月 22 日

On-Demand Webinar

Extending the Value of Antibody–Drug Conjugates: Model-Informed Labeling, Expansion, and Market Access

Learn how model-informed strategies support ADC labeling, dose optimization, and market access through integrated evidence…

Certara2026 年 4 月 10 日

Certara 服务

BioSpace webinar: Streamlining Nonclinical Development with FDA NAMs

Designing Drug Development Programs for Reimbursement Success

Population Pharmacodynamic Modeling of Plozasiran for Treatment of Familial Chylomicronemia Syndrome

Population Pharmacokinetics and Exposure-Response Analysis of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1 Mutation

Population Pharmacokinetic Modeling and Exposure-Response Analyses of Nemtabrutinib in Patients With Hematologic Malignancies

The one-trial era: what the FDA’s shift signals for the future of drug development

Optimize readiness for MHRA-NICE aligned pathway

Understanding LC/MS/MS

Certara Talks – Pivotal Trial Mandate

Extending the Value of Antibody–Drug Conjugates: Model-Informed Labeling, Expansion, and Market Access

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