pre-update Archives

Blog

Maximizing Reusability for Drug Submissions to Different Health Authorities

Many drug developers have products that they want to submit for marketing approval in several…

CertaraSeptember 21, 2023

Poster

FDA Trends for Accelerated Drug Approvals in Oncology Indications

The FDA has modified and increased expectations around data needed to support accelerated approvals in…

CertaraSeptember 20, 2023

Poster

Adoption of PROs in Early Clinical Trials for Oncology Drugs: Challenges and Opportunities

Despite changes in regulatory expectations, adoption of PROs in early-phase oncology trials remains very low…

CertaraSeptember 20, 2023

Poster

PBPK Application in Drug Discovery and Development

Real-World Application of Physiologically Based Pharmacokinetic Modeling (PBPK) in Support of Decision-Making During Drug Discovery;…

CertaraSeptember 20, 2023

Blog

Top Lessons Learned from 300 Regulatory Submissions

Who would have thought when we completed work on the first submission for which we…

CertaraSeptember 20, 2023

Announcement

Certara launches Phoenix Hosted, a cloud-based solution of Phoenix™ software

Certara launches Phoenix Hosted, a cloud-based solution of Phoenix™ software PRINCETON, N.J.— September 19, 2023…

CertaraSeptember 19, 2023

Press Release

Certara Announces 300th Regulatory Submission Milestone Using its Technology-enabled Services and Software

Dedicated team of global regulatory experts delivers submissions in increasingly shorter timelines. PRINCETON, NJ –…

CertaraSeptember 19, 2023

Fact Sheet

Simcyp™ Biopharmaceutics Factsheet

Elevating ‘Gold Standard’ PBPK Technologies for Biopharmaceutics, Drug Formulation, and CMC Experts

CertaraSeptember 18, 2023

Blog

What is ICER & How Does it Impact the Pharmaceutical Industry?

The Institute for Clinical and Economic Review (ICER) is a US Health Technology Assessment organization.…

CertaraSeptember 15, 2023

Poster

Modelling of the in vitro Biokinetics of Tebufenpyrad for in vivo Dose Estimation

CertaraSeptember 14, 2023

pre-update

Maximizing Reusability for Drug Submissions to Different Health Authorities

FDA Trends for Accelerated Drug Approvals in Oncology Indications

Adoption of PROs in Early Clinical Trials for Oncology Drugs: Challenges and Opportunities

PBPK Application in Drug Discovery and Development

Top Lessons Learned from 300 Regulatory Submissions

Certara launches Phoenix Hosted, a cloud-based solution of Phoenix™ software

Certara Announces 300th Regulatory Submission Milestone Using its Technology-enabled Services and Software

Simcyp™ Biopharmaceutics Factsheet

What is ICER & How Does it Impact the Pharmaceutical Industry?

Modelling of the in vitro Biokinetics of Tebufenpyrad for in vivo Dose Estimation

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