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
Preparing Vaccine Studies for Regulatory Submissions
In this webinar, Michael Beers reviews FDA, PMDA, and CDISC guidance for preparing vaccine studies…
CertaraSeptember 10, 2021
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
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
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
Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification
Aripiprazole lauroxil (Aristada®) was approved by the FDA for treating schizophrenia in adults in October…
CertaraAugust 12, 2021
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…
CertaraAugust 12, 2021
Succeeding in Value Communication: Introduction
Drawn from the experiences of the BaseCase Consulting Team, this is the introduction to ‘Succeeding…
CertaraAugust 5, 2021
DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®)
Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare…
CertaraJuly 29, 2021
