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Announcement

Certara collaborates with Korea Institute of Toxicology to ensure FDA submission-ready SEND dataset

Software will aid optimizing pre-clinical data management in accordance with global standards and guidelines. Seoul,…

CertaraAugust 3, 2023

Blog

Drug Manufacturers’ Recent Drop in Insulin Prices in the United States

The prevalence of diabetes in the US is incredibly high and affects more than 10%…

CertaraAugust 3, 2023

On-Demand Webinar

How value communication can make or break your commercial success?

Are you struggling to effectively communicate the value of your products or services in today's…

CertaraAugust 2, 2023

Announcement

Certara and Drugs for Neglected Diseases initiative (DNDi) Partnering to Fast-track Data Submissions and Accelerate Drug Approvals for Neglected Patients

DNDi Utilizing Pinnacle 21 Enterprise (P21E), Certara’s Data Science platform for Biostatistics, Data Management, and…

CertaraJuly 31, 2023

On-Demand Webinar

How Can Model-Informed Drug Development Accelerate Your Program?

What is model-informed drug development (MIDD), and why is it so critical to informing the…

CertaraJuly 28, 2023

White Paper

ICER’s Unsupported Price Increase Report: Unfit for Policymaking

Since 2019, the Institute for Clinical and Economic Review (ICER) has published an annual Unsupported…

CertaraJuly 25, 2023

Publication

Proof of Concept in Assignment of Within-Subject Variability During Virtual Bioequivalence Studies: Propagation of Intra-Subject Variation in Gastrointestinal Physiology Using Physiologically Based Pharmacokinetic Modeling

While the concept of ‘Virtual Bioequivalence’ (VBE) using a combination of modelling, in vitro tests and integration…

CertaraJuly 21, 2023

Blog

Simcyp™ Compound Summaries Library: What is it & why should you use it?

In the world of pharmacokinetic/dynamic (PBPK/PD) modelling, compound PBPK models are incorporated into compound files…

CertaraJuly 21, 2023

On-Demand Webinar

RAPS Sponsored Webcast: How to Plan for a Successful EMA Policy 0070 Submission

In September 2023, the European Medicines Agency (EMA) will reinstate their Policy 0070 requirement to…

CertaraJuly 20, 2023

Blog

Change Management – An Important Part of Good Manufacturing Practice (GMP)

You are having a good day as a quality assurance professional at a small pharmaceutical…

CertaraJuly 14, 2023

Certara collaborates with Korea Institute of Toxicology to ensure FDA submission-ready SEND dataset

Drug Manufacturers’ Recent Drop in Insulin Prices in the United States

How value communication can make or break your commercial success?

Certara and Drugs for Neglected Diseases initiative (DNDi) Partnering to Fast-track Data Submissions and Accelerate Drug Approvals for Neglected Patients

How Can Model-Informed Drug Development Accelerate Your Program?

ICER’s Unsupported Price Increase Report: Unfit for Policymaking

Proof of Concept in Assignment of Within-Subject Variability During Virtual Bioequivalence Studies: Propagation of Intra-Subject Variation in Gastrointestinal Physiology Using Physiologically Based Pharmacokinetic Modeling

Simcyp™ Compound Summaries Library: What is it & why should you use it?

RAPS Sponsored Webcast: How to Plan for a Successful EMA Policy 0070 Submission

Change Management – An Important Part of Good Manufacturing Practice (GMP)

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