Veristat’s Post

Advancing therapies intended to treat pediatric patient populations is highly complex with numerous confounding challenges. With this, trial design and conduct come with heightened scrutiny for regulatory, ethical, and safety standards for children as patients. 🆕Watch our latest video today to discover how Veristat can help design and run your next pediatric clinical development studies📽️ https://bit.ly/3Us4BMK #Pediatric #PediatricClinicalDevelopment

#GCT_NEWS GCT completes enrollment for a Respiratory Pediatric Phase IV Clinical Trial GCT is thrilled to announce the successful completion of enrollment for a Respiratory Pediatric Phase IV Clinical Trial. Notably, we concluded the recruitment phase two months ahead of schedule, a testament to the dedication of our colleagues in Bulgaria and Romania, as well as our motivated Investigators and site staff. This study aims to assess the efficacy and safety of an alcohol-free spray and lozenges in pediatric patients (6-12 years) with sore throat. We are proud to collaborate on this endeavor with our longstanding partner, ZAK-Pharma Dienstleistung Ges.m.b.H. https://lnkd.in/dca7ddj7 #enrollment #patients #pediatric #respiratory #clinicaltrial #CRO #GCT #clinicalresearch #globalclinicaltrials #gctrials #contractresearchorganization #pharma #clinicaloperations #drugdevelopment #GlobalClinicalTrials #clinicaltrials #GCP #biotech #clinicalresearchorganization #collaboration #partnership #sorethroat

📢 The EFGCP Better Medicines for Children Virtual Pre-Conference 2023 will take place in a month, register now and join us for a half-day of intense discussions and case studies on Pediatric Dose Optimization! #Pediatric #Dose #Optimization 12 Oct. 2023 | Half Day Virtual Meeting | Zoom Dose optimization is integral to maximizing pediatric medicines development. Variability in #pharmacokinetic and #pharmacodynamic parameters across the pediatric population by size and/or age can increase the complexity associated with identifying the optimized dose for use of a new medicine. Understanding how to design and optimize selection of a pediatric dose leveraging existing data, employing dose-finding designs that maximize small patient numbers, or utilize quantitative approaches, is essential to maximizing safety, effectiveness and tolerability of new pediatric medicines. This workshop has been designed to provide pediatric #researchers, trial #sponsors, and #regulatory reviewers an opportunity to actively engage with experts on the fundamentals of developing a #strategy for pediatric dose optimization. Attendees will participate in interactive small group discussions utilizing case examples. Experts will guide attendees through the development of an anonymized pediatric dosing strategy utilizing two case examples – determining the relevance of available data for use in the pediatric program design, analysing whether model-informed approaches are appropriate, and/or evaluating and proposing study designs. More information and registration: https://lnkd.in/eti2S4kV #children #medicines #paediatrics #clinicaltrials

Characteristics and clinical presentations of pediatric retinoblastoma in North-western Iran

In this #blog, Nazim Kanji, Executive Director of Pediatric Services, discusses how strong sponsor and CRO/CDMO partnerships help streamline orphan/rare and #pediatric drug development. He also details a case study where #QuotientSciences worked on a high level of customization of a drug product to support an extensive Phase II/III clinical program. Read more: https://bit.ly/4cv54G9

Dose optimization is critical in pediatric medicines development to ensure that a safe and efficacious dose is correctly administered to children. Variability in the pediatric population by size and/or age can alter exposure and subsequently the desired response. Understanding how to select the ideal pediatric dose can be accomplished by leveraging existing data, employing dose-finding study designs that maximize small sample sizes, utilizing quantitative approaches, and employing simulations to maximize the probability of the administration of a safe and effective dose of new pediatric medicines. This EFGCP workshop has been designed to provide an opportunity to actively engage with experts on the fundamentals of developing a strategy for pediatric dose optimization. #pediatrics, #children, #pharmacokinetics, #pharmacodynamics, #regulatory, #clinicaltrials, #dose, #optimization

🌟 Exciting Pediatric Clinical Trials Webinar Alert! 🌟 During this webinar, you'll gain valuable perspectives on collaborating with patient advocacy organizations, engaging with patients' families and implementing patient-centered trial principles to enhance recruitment, streamline the patient consent process and promote adherence to protocols! Register now: https://buff.ly/3snl4aI #Pediatrics #PediatricClinicalTrials #ClinicalDevelopment #DrugDevelopment #RareDiseases

💨(2/3) The six “P”s of rapid sequence intubation are preparation, preoxygenation, pretreatment, paralysis and induction, placement of tube, and postintubation management. This provides a systemic approach to optimize intubating conditions and management. Before we decide on paralyzing someone, always think pretreatment. The acronym “LOAD” was utilized in the past for severe TBIs to mitigate elevations in ICPs. LOAD stands for lidocaine, opioids, atropine, and defasciculation dosing. The purpose of pretreatment is to blunt the sympathetic response to an endotracheal tube being passed. Lidocaine and opioids were considered neuroprotective, but literature more supports the latter. Succinylcholine can cause bradycardia, especially in pediatrics, hence the use of prophylactic atropine. Defasculation dosing utilized a small dose of rocuronium with succinylcholine to prevent defasiculations. Evidence outside of opioids do not support routine use. 💥Watch the rest of the #PHARMFAX Rapid Sequence Intubation (RSI) Pretreatment Reel on my page (2/3)! Did you save the #PHARMFAX for later? Hit the like and follow button for more, share the #PHARMFAX with a friend, and I hope you learned something new. The ALL PHARMWYZE SOURCE (including references): https://zurl.co/g6Ry Recommended Read/Watch RSI Agents Overview: https://zurl.co/ZsZE RSI Agents Pharmacokinetics: https://zurl.co/BzeX #rapidsequenceintubation #load #rsi #lidocaine #atropine #opioids #defasciculationdosing #access #down #delayed #foamed #pharmacist #pharmwyze #pharmfax #criticalcare #emergencymedicine #studentpharmacist #nursingstudent #medicalstudent #pharmacy #medicine #nursing #meded

The clinical application of paediatric serum troponin T testing remains a topic of debate. While serum troponin testing can aid in diagnosing suspected cardiac ischaemia in adults, its utility in paediatric patients with chest pain is limited due to the rarity of cardiac ischaemia in this population. Despite its widespread use in adult populations, current literature suggests caution in relying on serum troponin testing alone for diagnosing chest pain in children, given its multifactorial nature. Further research is needed to determine the optimal diagnostic approach for paediatric patients presenting with chest pain. #Pediatrics #CardiacIschaemia #TroponinTesting 🩺👶❤️

Congress is in discussion of reauthorizing the FDA's Pediatric Rare Disease Priority Review Voucher (PRV) Program. This program has been crucial in accelerating the development and approval of treatments for rare pediatric conditions, enabling life-saving therapies to reach children in need more swiftly. The PRV program incentivizes pharmaceutical companies to prioritize rare diseases, a critical area of healthcare. With its expiration imminent, prompt congressional action is necessary to sustain this vital program. Reauthorizing the PRV program is essential for maintaining progress in the fight against rare pediatric diseases and improving patient outcomes. #HealthcareInnovation #PediatricCare #RareDiseases #FDA