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On-Demand Webinar

Approaches to Address the Regulatory Requirements for System Qualification of the Simcyp Simulator

Physiologically-based pharmacokinetic (PBPK) modeling is being increasingly used in drug development to avoid unnecessary clinical…

CertaraMay 9, 2022

Poster

Prediction of drug-drug interactions with oxycodone and pupil constriction using a physiologically based pharmacokinetic-pharmacodynamic model

Poster

CertaraApril 29, 2022

Announcement

P21 Adds Support for CDISC Open Rules Engine (CORE)

P21 is proud to announce that support for CDISC Open Rules Engine (CORE) is now available…

CertaraApril 25, 2022

Announcement

Pinnacle 21 Releases P21 Community 4.0

As of April 25, 2022, we have released P21 Community 4.0 to general availability! Install…

CertaraApril 25, 2022

On-Demand Webinar

Smarter Clinical Document Automation for Transparency and Disclosure Requirements

Transparency and disclosure efforts are an integral part of medical writing for submissions. Sponsors receive…

CertaraApril 14, 2022

Case Study

PBPK Model Informs Antibody-Drug Conjugate Label for DDIs Without Clinical Trials

Genentech was developing polatuzumab vedotin (Polivy), an anti-CD79b-vc-monomethyl auristatin E (MMAE) antibody-drug conjugate (ADC) to…

CertaraApril 11, 2022

Blog

5 Reasons Why You Should Use Phoenix WinNonlin for PK/PD Analyses

Pharmaceutical companies around the globe face the challenge of increasingly longer drug development cycles and…

CertaraMarch 25, 2022

Fact Sheet

SEND Explorer – Product Family

Discover how SEND Explorer transforms nonclinical data analysis.

CertaraMarch 23, 2022

On-Demand Webinar

eChalk Talk: How Oncology Drug Developers Can Prepare for FDA’s Project Optimus

Historically, the dosing strategy for oncology drugs has focused on use of the maximum tolerated…

CertaraMarch 22, 2022

Video

The Value of BaseCase

CertaraMarch 21, 2022

Approaches to Address the Regulatory Requirements for System Qualification of the Simcyp Simulator

Prediction of drug-drug interactions with oxycodone and pupil constriction using a physiologically based pharmacokinetic-pharmacodynamic model

P21 Adds Support for CDISC Open Rules Engine (CORE)

Pinnacle 21 Releases P21 Community 4.0

Smarter Clinical Document Automation for Transparency and Disclosure Requirements

PBPK Model Informs Antibody-Drug Conjugate Label for DDIs Without Clinical Trials

5 Reasons Why You Should Use Phoenix WinNonlin for PK/PD Analyses

SEND Explorer – Product Family

eChalk Talk: How Oncology Drug Developers Can Prepare for FDA’s Project Optimus

The Value of BaseCase

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