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…

Jim Gallagher2022年4月11日

Announcement

P21 Releases New PMDA Validation Engine

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

Certara2021年12月20日

On-Demand Webinar

Exploring Changes in SDTMIG 3.4 & ADaMIG 1.3

On November 29th 2021, CDISC released updated versions of SDTM and ADaM, including standardized structures…

Danielle Pillsbury2021年12月16日

Blog

Industry Metrics for CDISC Controlled Terminology

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

Certara2021年11月17日

White Paper

新薬のマーケットアクセスを成功に導くためのリアルワールドエビデンスの利用

Jim Gallagher2021年9月29日

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…

Jim Gallagher2021年9月23日

Case Study

Simcyp Simulator を使用した小児における Guanfacine の DDI 責任の判定

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

Jim Gallagher2021年8月26日

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…

Jim Gallagher2021年8月26日

Case Study

Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification

Aripiprazole lauroxil (Aristada®) was approved by the FDA for treating schizophrenia in adults in October…

Jim Gallagher2021年8月12日

Case Study

PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib

Cobimetinib (Cotellic®), approved by the US FDA in 2015, is a kinase inhibitor for treating…

Jim Gallagher2021年8月12日

サターラの製品

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

P21 Releases New PMDA Validation Engine

Exploring Changes in SDTMIG 3.4 & ADaMIG 1.3

Industry Metrics for CDISC Controlled Terminology

新薬のマーケットアクセスを成功に導くためのリアルワールドエビデンスの利用

The Scary Future of Rare Disease Management

Simcyp Simulator を使用した小児における Guanfacine の DDI 責任の判定

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

Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification

PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib

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