Preparing Vaccine Studies for Regulatory Submissions Blog Post
In this webinar, Michael Beers reviews FDA, PMDA, and CDISC guidance for preparing vaccine studies for regulatory submissions.
SDTM Trial Summary Domain Puzzle: Are These the Right Pieces? Blog Post
SDTM Trial Summary (TS) domain is essential for regulatory submission and is part of FDA rejection criteria. TS can be complex to implement with guidance spread across SDTMIG, FDA Study...
Pediatric Drug Development: Optimizing Extrapolation Blog Post
Optimizing the use of the extrapolation concept in pediatric investigational programs: Here are 4 key considerations. Drug development in pediatrics continues to be a substrate for the application of innovative...
Using Simcyp Simulator to Determine DDI Liability of Guanfacine in Children Blog Post
Guanfacine (Intuniv® XR) extended release (GXR) is an orally administered, selective alpha2A-adrenergic receptor agonist, non-stimulant treatment for children and adolescents with attention deficit/hyperactivity disorder (ADHD). Guanfacine is primarily metabolized by...
Using a PBPK-PD Receptor Occupancy Model to Determine the Optimal Dose of Radiprodil for Neonates Blog Post
Radiprodil is a selective allosteric modulator of the NR2B N-methyl-D-aspartate receptor GluN2B-NMDA that was being investigated to treat infantile spasm syndrome. Alongside clinical trials, a radiprodil physiologically-based pharmacokinetic-pharmacodynamic (PBPK-PD) model...
Bridging Formulations of Quetiapine for Children with Schizophrenia or Bipolar Disorder Blog Post
Quetiapine is an atypical antipsychotic for treating schizophrenia, bipolar depression, bipolar mania that helps to restore the balance of certain natural substances (neurotransmitters) in the brain. Changing the formulation of...
Simcyp’s Age-Defining Feature Facilitates Everolimus Dosing in Neonates Blog Post
Everolimus (Afinitor®) was recently approved as adjunctive therapy for tuberous sclerosis complex (TSC)-associated partial seizures in ages 2 and older. Unlike many other therapies for treating TSC-associated seizures, everolimus addresses...
Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs Blog Post
In 2014, Eliglustat (Cerdelga®) was approved by the FDA as the first long-term treatment for adults with type 1 Gaucher disease. Eliglustat is an oral inhibitor of glucosylceramide synthase. It...
