Eunjin Hong’s Post

🌟💊Safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 685509 We are proud to announce that our very own clinical research investigator, Friedeborg Seitz, was a key contributor to a recent study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 685509 in healthy volunteers. The study, conducted through rigorous Single Rising Dose (SRD) and Multiple Rising Dose (MRD) trials, provided valuable insights into the effects and potential of BI 685509. Highlights include: SRD Trial: 24 participants received single doses of BI 685509 or placebo, with key findings showing rapid absorption and dose-proportional exposure. MRD Trial: 60 participants received varying doses over 14–17 days, with observations of decreased orthostatic dysregulation over time and near-dose-proportional increases in exposure. The study confirmed BI 685509 was generally well tolerated, with manageable side effects. Join us in celebrating this achievement and the ongoing dedication of our team to excellence in clinical research! 👨🔬🔬 Read the full study here: https://lnkd.in/eC-6PwEd #CRS #Innovation #ClinicalResearch #PursuitofExcellence #Mannheim

How to overcome the methodological limitations of conventional PK studies in renal & hepatic impairment? Vivek Purohit – he recently contributed as speaker at the last Global Bioequivalence Harmonisation Initiative with modelling approaches for BE setting – together with colleagues from Pfizer just published an interesting approach in the AAPS Journal: this approach utilised prior population pharmacokinetic (PopPK) modeling-based simulation to conclude on the distribution of exposure ratios between the renally impaired / hepatically impaired PK arms and those with healthy subjects. But have a look by yourself - the open access article can be downloaded: https://lnkd.in/eB2GtbSN In my eyes the advantage is not the avoidance of the healthy subjects’ arm – this is normally according to our experience at SocraTec R&D not an issue – but to overcome application of inadequate inferential statistics. So far Vivek and his colleagues tested a series of studies. Maybe, one could use both approaches in parallel until more experience is gathered? #renalImpairment, #hepaticImpairment, #earlyphasetrial

Laura Dormer, Editor of The Evidence Base®, shares her Editor’s picks from the June issue of the Journal of Comparative Effectiveness Research, partner journal of The Evidence Base. This month, Sreeram Ramagopalan (LCP Health Analytics) et al. discuss the potential impact of the European Union #JCA on patients with a #raredisease. William Gray (Thomas Jefferson University) et al. discuss the IMPERIAL study compared the use of a #paclitaxel-eluting polymer-coated stent (Eluvia) with a polymer-free paclitaxel-coated stent (Zilver PTX) in the treatment of femoropopliteal arterial segment. Jason Shafrin (FTI Consulting) et al. cover the cost–effectiveness of sotagliflozin for the treatment of patients with #diabetes and recent worsening #heartfailure. #heor #healtheconomics #outcomesresearch #rwe #rwd #realworldevidence #realworlddata #marketaccess #pharma #biopharma #medicalaffairs #hta #healthtechnologyassessment #healthdata #healthequity #healthpolicy #cardiovasculardisease

C-Path’s T1D Consortium and Quantitative Medicine Program assisted the team University of Florida with the creation of a clinical trial simulation tool and corresponding article titled "Type 1 Diabetes Prevention Clinical Trial Simulator: Case Reports of Model-informed Drug Development Tool." The article was recently published in CPT: Pharmacometrics & Systems Pharmacology and focuses on the development of a disease progression model-based CTS tool using individual-level data collected from multiple sources. The goal of this tool is to help design more efficient clinical trials that will prevent or delay the onset of T1D. Within the article, the tool is described in depth along with instructions on how to use the tool and case studies. ⏩ Access the article here: https://lnkd.in/gd8mefC3 ⏩ The web-based tool is publicly available here: https://lnkd.in/g_aFYKWk ⏩ Information on C-Path's T1DC here:  https://lnkd.in/g9s6mzJ7 Juan Francisco Morales Jagdeep Podichetty, PhD Jackson Burton Klaus Romero Inish O'Doherty, Ph.D. Sarah Kim Sarah David ASCPT Journal Family #CPath #T1D #ASCPTJournalFamily #PSPJournal #drugdevelopment #datasharing #collaboration #globalhealth #diabetes

Here is a publication of a peer-reviewed Phase 1 study of a novel intranasal formulation of #BPL003 by #BeckleyPsytech in The Journal of Psychopharmacology. The synthetic intranasal benzoate salt formulation of 5-MeO-DMT (also known as mebufotenin) was relatively well tolerated in combination with psychological support by 44 psychedelically unaffected healthy volunteers. BPL-003 showed a desired dose-proportional increase in pharmacokinetic -(PK) and pharmacodynamic (PD) effects. The short duration of action and the more than adequate results of the Mystical Experience Questionnaire (#MEQ30) as well as the correlation with the Ego Dissolution Inventory (#EDI) suggest a clinical potential that warrants further investigation.

We at SAIA are excited to share the latest research published in the Indian Journal of Gastroenterology! Read here: https://lnkd.in/eF7H3ntz   The rising prevalence of inflammatory bowel disease (IBD) in developing countries highlights the need for clear guidelines on the use of advanced therapies. An expert consensus document has been created in collaboration with many SAIA members to guide clinicians on the usage of tofacitinib, an oral Janus kinase inhibitor, in treating ulcerative colitis in developing nations.   Tofacitinib is effective for inducing and maintaining remission in ulcerative colitis, particularly in cases of biological failure or refractory disease. And in the developing world, the Tofa pill is much cheaper and readily more available that #biologics are, making it an easier option for gastroenterologists to prescribe and patients to accept even as a first-line therapy.   While exact positioning of Tofa is still unknown, this consensus guideline is extremely important in that it brings together some of the greatest clinical and research minds in the Indian #IBD space to brainstorm the best path forward. #SouthAsianIBDAlliance #SAIA #IBDesis #ulcerativecolitis #colectomy #jpouch #fistula #Crohns #research #patientadvocacy #SouthAsianIBD #desi #logkyakahenge #tofacitinib

🔬 **Breaking News: FDA Approves Array of Novel Drugs in 2023—A Win for Healthcare Advancement!** 📅 On January 9, 2024, the FDA (CDER) made remarkable strides by approving an extensive range of innovative drugs, revolutionizing healthcare in diverse disease areas. The approvals encompass breakthroughs in infectious diseases (including COVID-19 and RSV), neurological conditions, rare diseases, and more. 🌟 **Key Highlights:** - **Rare Disease Focus:** Over half of the novel drugs (51%) aim to treat, diagnose, or prevent rare conditions, earning them an orphan-drug designation. - **Critical Areas:** Approvals cover treatments for different types of anemia, chronic weight management, heart, blood, kidney, and endocrine disorders. - **Specialized Approvals:** Five biosimilars and medications for rare cancers have also been greenlit, marking pivotal advancements in specialized treatments. 👩⚕️ These approvals signify a monumental leap in medical innovation, elevating hopes for patients and consumers. The FDA's dedication to fostering research and development yields transformative solutions, improving lives across various healthcare spectrums. 📚 **Read more about the FDA approvals and their impact on healthcare advancements.** https://lnkd.in/gUcDfxuy #FDAApproval #HealthcareAdvancements #NovelDrugs #RareDiseases #Innovation #Biotechnology #Pharmaceuticals #MedicalResearch #HealthcareNews #OrphanDrugs #COVID19Treatment #Biosimilars #Neurology #Diabetes #PatientCare #MedicalBreakthroughs #LifeSciences #PublicHealth More Contents: Woongsik Dr. Su, MBA ---

Most read and cited article in Movement Disorder Journal: Levodopa Dose Equivalency in Parkinson's Disease: Updated Systematic Review and Proposals. New drugs with novel mechanisms of action and novel formulations of existing medications for PD have been developed over the last decade. A new proposal for Levodopa Equivalent Dose (LED) conversion formulae is required to facilitate research on the clinical efficacy of pharmacological and surgical treatments as well as other non-pharmacological interventions in PD. My excellent colleagues from different centres, led by myself and Professor Haidar Dafsari, came together to review over 680 research articles across PD cohorts through a standardized process. We hope that this Position Paper will serve as a useful research tool for comparison of equivalence of antiparkinsonian medications for a wide range of drugs that are currently available for the pharmacotherapy of PD or are expected to be introduced soon. #parkinsons https://lnkd.in/dchb32Ar

Publication alert 📢 Alhamdulillah, I'm beyond thrilled to announce that my first research article has been published in the IJBMS Journal 🌟 Our study reveals that Saroglitazar significantly suppresses Kidney Injury Molecule-1 (KIM-1) and type IV collagen in HFD and low dose STZ-induced diabetic nephropathy in Wistar rats. This breakthrough has significant implications for the management and treatment of diabetic nephropathy, a leading cause of chronic kidney disease (CKD) and end-stage renal failure. I'm grateful for the unwavering support of my Research Supervisor Prof. Uma Bhandari Ma'am, my senior Dr. Sayima Nabi, and peers, who believed in me and pushed me to strive for excellence. As I celebrate this success, I'm reminded that research is a journey, not a destination. I'm excited to continue pushing boundaries, exploring new frontiers, and making a positive impact in the healthcare field! Read the full article here: https://lnkd.in/dnTrZj3y #research #publication #IJBMS #CKD #innovation #pharmacy #healthcare #jamiahamdard

🌺 Today I want to share that our remarkable work entitled "Clinical pharmacokinetics of nebivolol: a systematic review" has been published today in journal of "Drug Metabolism Reviews" with impact factor of 6.987.. 🌺 Highly proud on co-supervising a talented student of M.Phil and highly obliged to my mentor Prof. Dr. Muhammad Fawad Rasool for giving me the opportunity to disseminate my knowledge and skills to my younger ones. #nebivolol #systematicreview #pharmacokinetics #achievement