Publication

Relative Bioavailability of Single-Dose Oral Administration of Two SHR7280 Formulations (Dry Suspension and Tablets) in Healthy Chinese Volunteers

Explore how Dry suspension and tablet SHR7280 formulations show comparable bioavailability and safety in a…

CertaraAugust 8, 2025

Blog

Replacing traditional TQT studies with model-based concentration-qtc (C-qtc) analysis for cardiovascular safety in drug development

Learn how our experts use concentration-QTc (C-QTc) analysis to replace costly TQT studies, streamline QT…

CertaraAugust 6, 2025

On-Demand Webinar

Understanding Antibody-Drug Conjugates (ADCs) Pharmacokinetics From NCA to Population PK Approaches

CertaraAugust 1, 2025

Case Study

Optimizing Dosing and Regulatory Outcomes in Duchenne Muscular Dystrophy (DMD) Drug Development

Certara supported DMD drug development for Givinostat, helping Italfarmaco with pharmacometric and regulatory strategy.

CertaraJuly 29, 2025

On-Demand Webinar

MIDD Strategies for Preclinical and Clinical Translation: A Collaboration Between Clinical Pharmacologists and Modeling Disciplines

Learn how clinical pharmacologists and modeling experts collaborate to improve preclinical-to-clinical translation.

CertaraJuly 29, 2025

Conference

AusBiotech International Conference 2025

CertaraJuly 25, 2025

Blog

ADNCA explained: The next generation of non-compartmental analysis and the top questions answered

ADNCA is transforming non-compartmental analysis by standardizing workflows, enhancing regulatory confidence, and enabling scalable automation.…

CertaraJuly 23, 2025

Publication

An Observational Study on the Pharmacokinetics of Levofloxacin in Lactating Atypical Pneumonia Patients

Discover how breastmilk PK shows low infant exposure to levofloxacin, supporting cautious breastfeeding during therapy,…

CertaraJuly 17, 2025

Blog

MIDD can ease pediatric & rare disease drug loss in Japan

Certara tackles pediatric cancer and rare disease drug loss in Japan by advocating MIDD, which…

CertaraJuly 8, 2025

Case Study

Accelerating Oncology Drug FDA RTOR Submission with Project Management Services

Discover how Certara’s dedicated project management and pharmacometric support helped an emerging biotech company fast-track…

CertaraJuly 2, 2025

Clinical Pharmacology

Relative Bioavailability of Single-Dose Oral Administration of Two SHR7280 Formulations (Dry Suspension and Tablets) in Healthy Chinese Volunteers

Replacing traditional TQT studies with model-based concentration-qtc (C-qtc) analysis for cardiovascular safety in drug development

Understanding Antibody-Drug Conjugates (ADCs) Pharmacokinetics From NCA to Population PK Approaches

Optimizing Dosing and Regulatory Outcomes in Duchenne Muscular Dystrophy (DMD) Drug Development

MIDD Strategies for Preclinical and Clinical Translation: A Collaboration Between Clinical Pharmacologists and Modeling Disciplines

AusBiotech International Conference 2025

ADNCA explained: The next generation of non-compartmental analysis and the top questions answered

An Observational Study on the Pharmacokinetics of Levofloxacin in Lactating Atypical Pneumonia Patients

MIDD can ease pediatric & rare disease drug loss in Japan

Accelerating Oncology Drug FDA RTOR Submission with Project Management Services

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