PK Submit™ Overview
Learn how PK Submit accelerates NCA workflows and ensures regulatory compliance.
CertaraOctober 12, 2022
Certara Announces New Release of PK Submit
PRINCETON, N.J.— October 12, 2022 – Certara, Inc., a global leader in drug development software,…
CertaraOctober 12, 2022
The Growing Value of Quantitative Systems Pharmacology (QSP)
Gain a foundational understanding of QSP in this 101-level article with examples of QSP applied…
CertaraOctober 7, 2022
How to Define & Measure Clinical Endpoints to Optimize Your Oncology Drug Dosing
Historically, the dosing strategy for oncology drugs focused on the maximum tolerated dose. This has…
CertaraOctober 5, 2022
Choosing a Clinical Trial Transparency and Disclosure Vendor: Your Complete Checklist
Choosing the right technology and services vendor to support your organization’s transparency and disclosure (T&D)…
CertaraOctober 4, 2022
5 Steps to Satisfy New EU-CTR Requirements for Plain Language Summaries of Clinical Study Results
For the first time, the European Medicines Agency (EMA) has passed new regulations to help…
CertaraSeptember 27, 2022
EU-CTR Challenges Drug Developers Faced in the First 6 Months
Under European Union Clinical Trial Regulation 536/2014 (EU-CTR), replacing the EU Clinical Trial Directive (Directive…
CertaraSeptember 26, 2022
Optimize drug development with public data and predictive models – model-based meta-analysis (MBMA)
Properly understanding the probability of successful drug development requires utilization of all available information. Critical…
CertaraSeptember 23, 2022
3 Takeaways from the FDA Oligo Guidance You Need to Know
In June 2022, the FDA published their first oligonucleotide clinical pharmacology specific guidance . This…
CertaraSeptember 23, 2022
