Case Study

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Discover how Certara applied exposure-response analysis and advanced modeling to optimize Donidalorsen dosing for hereditary…

CertaraNovember 10, 2025

On-Demand Webinar

Model-Informed Drug Development (MIDD) as a tool to Enhance Asset Value and Address Key Investor Concerns

In today’s market where long development timelines and investor caution can slow progress, MIDD offers…

CertaraNovember 10, 2025

On-Demand Webinar

Failure to Launch: Building Smarter Strategies to Get the Right Drug to the Right Patient

Watch the on-demand webinar on avoiding drug launch failure. Learn how smarter development, evidence, and…

CertaraNovember 6, 2025

Publication

Physiologically based pharmacokinetic model combined with a clinical lactation study to determine doravirine concentrations in human breastmilk

Discover how PBPK and clinical data show low infant exposure to doravirine during breastfeeding, supported…

CertaraNovember 6, 2025

Publication

Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation

This study demonstrates how model-informed approaches can improve dose selection decisions when direct clinical comparisons…

CertaraNovember 5, 2025

On-Demand Webinar

Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights

Watch this on-demand webinar to learn how pharmacometrics supports NDA, BLA, and global regulatory submissions.…

CertaraNovember 3, 2025

On-Demand Webinar

AAPS Webinar – Pediatric Drug Development: Why It’s Critical to Submission Strategy and How Modeling, Regulatory, and Clinical Insights Shape Success

Learn how model-informed drug development, clinical pharmacology, and regulatory strategy support successful pediatric drug development…

CertaraOctober 21, 2025

Publication

Randomized, Double-Blind, Phase I Pharmacokinetic Study of Subcutaneous Recombinant Human Superoxide Dismutase (rhSOD) in Healthy Volunteers

See how subcutaneous rhSOD shows sustained exposure and favourable safety compared with IV dosing, analysed…

CertaraOctober 18, 2025

Publication

Pharmacokinetics and Safety of Fospropofol Disodium for Injection in Subjects with Hepatic Impairment Compared with Healthy Matched Controls: A Prospective Cohort Study

Learn how faster fospropofol elimination but slower propofol clearance can help hepatic impairment, analysed using…

CertaraOctober 17, 2025

Blog

Streamlining PK/PD reporting: A smarter approach to generating tables, figures and listings

Discover how TFL Studio accelerates PK/PD reporting. Create audit-ready tables, figures, and listings faster with…

CertaraOctober 16, 2025

Clinical Pharmacology

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Model-Informed Drug Development (MIDD) as a tool to Enhance Asset Value and Address Key Investor Concerns

Failure to Launch: Building Smarter Strategies to Get the Right Drug to the Right Patient

Physiologically based pharmacokinetic model combined with a clinical lactation study to determine doravirine concentrations in human breastmilk

Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation

Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights

AAPS Webinar – Pediatric Drug Development: Why It’s Critical to Submission Strategy and How Modeling, Regulatory, and Clinical Insights Shape Success

Randomized, Double-Blind, Phase I Pharmacokinetic Study of Subcutaneous Recombinant Human Superoxide Dismutase (rhSOD) in Healthy Volunteers

Pharmacokinetics and Safety of Fospropofol Disodium for Injection in Subjects with Hepatic Impairment Compared with Healthy Matched Controls: A Prospective Cohort Study

Streamlining PK/PD reporting: A smarter approach to generating tables, figures and listings

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