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Blog

Formatting Annotated Case Report Forms (aCRFs): Not Submitted Annotations and SDRG

Simplify aCRFs with insights on “Not Submitted” annotations, reviewer’s guide tips, and define origin column…

CertaraNovember 13, 2020

Press Coverage

How PBPK Modeling Can Replace Drug-Drug Interaction Studies

Patients often take more than one drug at a time, especially elderly patients and those…

CertaraNovember 12, 2020

Case Study

Galderma Achieves FDA Approval of AKLIEF® (trifarotene)

In October 2019, Galderma announced that the U.S. FDA approved AKLIEF® (trifarotene) Cream, 0.005% for the…

CertaraNovember 9, 2020

Press Release

Certara Opens New China Office in Shanghai

Office will support rapid growth and collaboration with customers in China to accelerate biopharmaceutical R&D …

CertaraNovember 9, 2020

Video

D360 Overview

CertaraNovember 5, 2020

Publication

Danazol oral absorption modelling in the fasted dog: An example of mechanistic understanding of formulation effects on drug pharmacokinetics

CertaraOctober 30, 2020

Blog

Preparing CDISC Submissions for China’s NMPA

China’s NMPA now accepts CDISC submissions. To support this initiative, Pinnacle 21 has released a…

CertaraOctober 30, 2020

White Paper

The Effects of COVID-19 on Stakeholder Engagement & Value Communication: Preparing for the New Normal

CertaraOctober 28, 2020

Video

PBPK modeling supports approval of breakthrough cancer drug

Pharmacyclics’ (now AbbVie) Imbruvica (ibrutinib) is an anticancer drug targeting B-cell malignancies. Leveraging the US…

CertaraOctober 23, 2020

Brochure

Simcyp® Drug Labels