Delve into a discussion with experts from FDA and industry about MIDD Strategies in RNA-Based Oligonucleotide Drug Development in this upcoming #ASCPTwebinar. 4/24 at 12 pm ET: https://bit.ly/49MdUxw
American Society for Clinical Pharmacology & Therapeutics’ Post
More Relevant Posts
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New Blog Update! In our latest blog, we explore the key differences between the ICH M12 2024 and FDA 2020 DDI guidelines. Discover how the new harmonized approach impacts drug interaction studies, with insights into changes in terminology, enzyme inhibition, drug transporter studies, and more. A must-read for professionals in drug development! Read more here: https://hubs.ly/Q02CCp5R0 Get in touch with us to discuss your drug development projects - our experts can guide you through these recent changes: [email protected] #Cyprotex #Pharma #DrugDevelopment #ClinicalResearch #ICHM12
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Biosimilar Drug Delivery: Advancements and Current Development Pipeline" Discover the future of biosimilar drugs and their impact on new drug delivery. Learn about the current landscape of biosimilar development and the challenges that come with it. #BiosimilarInnovation #DrugDeliveryAdvances #BioPharmaPipeline #MedicalScienceProgress #NextGenMedicine #InnovativeTherapies #BiotechBreakthroughs #HealthcareRevolution #FutureOfPharma #BiosimilarPipeline
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Cancer-Killing New Drug Candidate Utilizing AI to Enhance FDA Investigational New Drug Research LINK: https://lnkd.in/ekq7WJgS Hashtags: #TodaysMedicalUpdate #Pharmaceutical #Medical #Research Please LIKE & REPOST
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Executive Business Services & Advisory Consultant | Based in Washington, DC | IT and Finance Program Management Specialist | 20 Years Exp. | Accenture, IBM, and KPMG, LLP Alum
Cancer-Killing New Drug Candidate Utilizing AI to Enhance FDA Investigational New Drug Research LINK: https://lnkd.in/eFx5A3Kw Hashtags: #TodaysMedicalUpdate #Pharmaceutical #Medical #Research Please LIKE & REPOST
Cancer-Killing New Drug Candidate Utilizing AI to Enhance FDA Investigational New Drug Research
tmcnet.com
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The Para IV Winners and Losers – May 2024 Track the Para IV space on a regular basis through our monthly report. The report is derived from our Para IV Insights – a database that covers all the Para IV litigations since 2012, both for Synthetic and Biosimilar drugs. The report answers the following questions for the month of May 2024: Which are the products were new Para IV filings have happened? Which products witnessed settlements and / or judgement? What opportunities emerge for companies based on the above developments? What are the key developments in the biosimilars space? For more information on the report and database – kindly contact us. #ParaIV #USgenerics #patent #505b(2) #settlement
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Latest issue published!
📢Explore research in pharmaceutical science with the latest issue of "Letters in Drug Design & Discovery." Volume 21, Issue 4 features articles on drug absorption, transdermal delivery, computational approaches, antibiofilm agents, and more. Stay at the forefront of drug development. 🌐📖 🔗 https://ow.ly/6POA50Q3n4K #PharmaCommunity #Research #BenthamScience
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The FDA has released a new guidance titled 'M12 Drug Interaction Studies'. The guidance provides general recommendations on evaluating the enzyme and transporter-mediated pharmacokinetic drug-drug interaction potential for investigational drugs. - Want to learn more about how this affects your drug development process? Get in touch with a member of the team www.scendea.com/contact - #drugdevelopment #regulatoryaffairs #interactionstudies
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The novelty, complexity and evolving regulatory guidance of oligonucleotide (oligo) therapies can create greater technical challenges for drug development than conventional drugs, but the right laboratory partner and technology can alleviate those challenges. Learn how to tackle the challenges of metabolite profiling and identification for oligo drug development. #MetID #oligonucleotide #Drugdevelopment https://hubs.li/Q027Lw-m0
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A lot of misperceptions and confusion out there. Here is a good explanation about the need to compound as a solution for #medication #shortages. There is a huge intentional tendency of confounding….. #compoundingpharmacy #medicationshortages
FDA guidance allows compounding pharmacies to make “essentially copies” of FDA-approved drugs when those drugs are listed as “currently in shortage” on the FDA drug shortage list — as both semaglutide and tirzepatide long have been. Reporters often ask us why compounded versions of those GLP-1s are so much less expensive than the branded drug. This report below appears to support what we tell those reporters: The active pharmaceutical ingredient in those drugs is inexpensive — and I would add: Compounding pharmacies aren’t looking to gouge their patients.
1 big number: Ozempic bloat
axios.com
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𝐅𝐃𝐀'𝐬 𝐌𝐨𝐝𝐞𝐥-𝐈𝐧𝐭𝐞𝐠𝐫𝐚𝐭𝐞𝐝 𝐄𝐯𝐢𝐝𝐞𝐧𝐜𝐞 (𝐌𝐈𝐄) 𝐈𝐧𝐝𝐮𝐬𝐭𝐫𝐲 𝐌𝐞𝐞𝐭𝐢𝐧𝐠 𝐏𝐢𝐥𝐨𝐭 𝐏𝐫𝐨𝐠𝐫𝐚𝐦 𝐟𝐨𝐫 𝐆𝐞𝐧𝐞𝐫𝐢𝐜 𝐃𝐫𝐮𝐠𝐬 𝐀𝐩𝐩𝐥𝐢𝐜𝐚𝐧𝐭𝐬🤝💊 𝘎𝘦𝘵 𝘍𝘋𝘈 𝘱𝘳𝘦-𝘢𝘱𝘱𝘳𝘰𝘷𝘢𝘭 𝘧𝘰𝘳 𝘺𝘰𝘶𝘳 𝘪𝘯 𝘴𝘪𝘭𝘪𝘤𝘰 𝘮𝘰𝘥𝘦𝘭𝘪𝘯𝘨 𝘢𝘯𝘥 𝘴𝘪𝘮𝘶𝘭𝘢𝘵𝘪𝘰𝘯 𝘢𝘱𝘱𝘳𝘰𝘢𝘤𝘩𝘦𝘴 𝘧𝘰𝘳 𝘨𝘦𝘯𝘦𝘳𝘪𝘤 𝘥𝘳𝘶𝘨 𝘥𝘦𝘷𝘦𝘭𝘰𝘱𝘮𝘦𝘯𝘵. The FDA, based on the #success of the MIDD (Model Informed Drug Development) program for #discovery that started in 2018, has now launched a similar program for #generics. The "Model-Integrated Evidence" (MIE) Industry Meeting Pilot Program for Generic Drugs, which was launched on 🗓️ October 1st, 2023. If you are thinking about using in silico for your generic #drugdevelopment program the MIE meeting is a new and essential program to help #validate your plan with the FDA and get pre-approvals. 🔗𝘊𝘭𝘪𝘤𝘬 𝘩𝘦𝘳𝘦 𝘵𝘰 𝘳𝘦𝘢𝘥 𝘵𝘩𝘦 𝘧𝘶𝘭𝘭 𝘣𝘭𝘰𝘨 𝘱𝘰𝘴𝘵 𝘢𝘯𝘥 𝘭𝘦𝘢𝘳𝘯 𝘮𝘰𝘳𝘦 𝘢𝘣𝘰𝘶𝘵 𝘵𝘩𝘦 𝘔𝘐𝘌 𝘗𝘪𝘭𝘰𝘵 𝘗𝘳𝘰𝘨𝘳𝘢𝘮. https://lnkd.in/ds74smFg FDA InSilicoTrials #FDA #GenericDrugs #MIEPilotProgram #InSilico #Modeling #Simulation #RegulatoryUpdates
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