Certara Products Archives

Case Study

Providing Around-the-Clock Regulatory Support While Enhancing Team Chemistry

Advaxis Inc. is devoted to the discovery, development, and commercialization of immunotherapies based on a…

CertaraJune 3, 2022

Case Study

PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA

In 2020, the US FDA approved Risdiplam (Evrysdi®) as the first orally administered drug to…

CertaraJune 2, 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

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

Conference

ASCPT 2026 Annual Meeting

CertaraMarch 7, 2022

Announcement

P21 Releases New PMDA Validation Engine

New PMDA Engine Pinnacle 21 is happy to announce the latest Validation Engine for submissions…

CertaraDecember 20, 2021

Blog

Industry Metrics for CDISC Controlled Terminology

Sergiy Sirichenko summarizes industry metrics across many studies and sponsors to produce an overall picture…

CertaraNovember 17, 2021

White Paper

Using Real-world Evidence to Advance Market Access for New Therapeutics

CertaraSeptember 29, 2021

On-Demand Webinar

The Scary Future of Rare Disease Management

In a world of rising healthcare costs, the greatest nightmare for payers is reimbursing drug…

CertaraSeptember 23, 2021

Certara Products

Providing Around-the-Clock Regulatory Support While Enhancing Team Chemistry

PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA

P21 Adds Support for CDISC Open Rules Engine (CORE)

Pinnacle 21 Releases P21 Community 4.0

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

ASCPT 2026 Annual Meeting

P21 Releases New PMDA Validation Engine

Industry Metrics for CDISC Controlled Terminology

Using Real-world Evidence to Advance Market Access for New Therapeutics

The Scary Future of Rare Disease Management

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