pre-update Archives

Blog

Highlights from the FDA-ASCO Workshop on Dose Optimization for Oncology Drugs

The FDA-ASCO (American Society of Clinical Oncology) workshop on oncology dose optimization (3-5 May 2022)…

CertaraJuly 8, 2022

On-Demand Webinar

Using Clinical Pharmacology & Pharmacometrics to Accelerate Cell Therapy Development: A Patient’s CAR-T Journey

Cell therapies aim to treat, prevent, or potentially cure diseases. They are a relatively new…

CertaraJuly 8, 2022

Blog

Why FDA’s New Guidance on Circulating Tumor DNA is Critical for Oncology Early Clinical Drug Development

2022 is shaping up to be the “year of the guidance” as the FDA has…

CertaraJuly 1, 2022

White Paper

Axendia: Improving Healthcare Outcomes by Rewarding Value, NOT Cost

This research examines the use of value-based communications to support the transition to fee-for-outcomes models…

CertaraJune 28, 2022

Video

Certara’s Simcyp Discovery Demo

View this software demo by Dr. Hannah Jones to learn about how Simcyp Discovery provides…

CertaraJune 28, 2022

Brochure

Writing at Lightspeed: Optimizing Submission Dossiers in Today’s Environment Through Better Planning

CertaraJune 24, 2022

Press Coverage

Utilizing Pharmacokinetic and Pharmacodynamic Modeling & Simulation Technologies for Anesthesiology and Pain Medicine

Today, we are interviewing Professor Gyujeong Noh from Anesthesiology and Pain Medicine/Clinical Pharmacology and Therapeutics…

CertaraJune 17, 2022

Brochure

Infographic- Project Optimus

What Oncology Drug Developers Should Expect from the FDA’s Project Optimus. With deep experience in…

CertaraJune 15, 2022

Blog

Reflections on the Recent ICH E11A Pediatric Extrapolation Guideline

The ICH E11A draft Guideline on Paediatric Extrapolation was released on 4 April 2022 entering a public…

CertaraJune 14, 2022

On-Demand Webinar

eCTD Submission Challenges

Industry standards are continually evolving, creating an environment of rapid change. With change comes challenges.…

CertaraJune 1, 2022

pre-update

Highlights from the FDA-ASCO Workshop on Dose Optimization for Oncology Drugs

Using Clinical Pharmacology & Pharmacometrics to Accelerate Cell Therapy Development: A Patient’s CAR-T Journey

Why FDA’s New Guidance on Circulating Tumor DNA is Critical for Oncology Early Clinical Drug Development

Axendia: Improving Healthcare Outcomes by Rewarding Value, NOT Cost

Certara’s Simcyp Discovery Demo

Writing at Lightspeed: Optimizing Submission Dossiers in Today’s Environment Through Better Planning

Utilizing Pharmacokinetic and Pharmacodynamic Modeling & Simulation Technologies for Anesthesiology and Pain Medicine

Infographic- Project Optimus

Reflections on the Recent ICH E11A Pediatric Extrapolation Guideline

eCTD Submission Challenges

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