Certara Products Archives

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

On-Demand Webinar

Preparing Vaccine Studies for Regulatory Submissions

In this webinar, Michael Beers reviews FDA, PMDA, and CDISC guidance for preparing vaccine studies…

CertaraSeptember 10, 2021

On-Demand Webinar

SDTM Trial Summary Domain Puzzle: Are These the Right Pieces?

TS can be complex to implement with guidance spread across SDTMIG, FDA Study Data Technical…

CertaraSeptember 10, 2021

Case Study

Using Simcyp Simulator to Determine DDI Liability of Guanfacine in Children

Guanfacine (Intuniv® XR) extended release (GXR) is an orally administered, selective alpha2A-adrenergic receptor agonist, non-stimulant…

CertaraAugust 26, 2021

Case Study

Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs

In 2014, Eliglustat (Cerdelga®) was approved by the FDA as the first long-term treatment for…

CertaraAugust 26, 2021

Certara Products

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

Preparing Vaccine Studies for Regulatory Submissions

SDTM Trial Summary Domain Puzzle: Are These the Right Pieces?

Using Simcyp Simulator to Determine DDI Liability of Guanfacine in Children

Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs

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