During clinical trials for combination products, delays in commercial launch often stem from the complex process of determining delivery parameters of the final combination product and conducting necessary bridging studies, leading to increased costs and risks. Elexy™ offers a robust solution to these challenges: ☑ Reusable power unit and flexible design: Elexy enables seamless adjustments in delivery parameters during dose-ranging studies. ☑ Compatibility with standard primary containers: Elexy integrates effortlessly with both pre-filled syringes and cartridge primary containers, circumventing the need for bridging studies and accelerating time-to-market. ☑ Integrated digital connectivity: Elexy facilitates the collection of richer clinical data, enhancing confidence when transitioning to commercial supply. Elexy streamlines clinical trials, helping pharma and biotech companies bring life-saving treatments to market faster. Download article https://lnkd.in/g4yCNE4i to learn more. #RedefinePossibilities #DrugDelivery
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Missed our live webinar on case study ID11916? Catch up on demand! Discover how a poorly soluble drug was turned into a high-performing formulation in just six weeks, even with scarce API availability. Our experts, Fabrizio Fina and Zsolt Lendvai, present the fascinating case study of ID11916. They explain how they transformed its initial water-insoluble state into an innovative oral formulation, accelerating its path to the human clinical trial phase. Don't miss out on this insightful session! https://hubs.ly/Q02KcfNp0 #bioavailability #preformulation #earlyformulation #drugdevelopment
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Discover best practices for meeting adequate particulate matter levels with Jorge Capurro, Director of Drug Delivery at Archimedic! One of the most important safety and performance endpoints for injectable combination products is to meet adequate particulate matter levels as specified in the USP and ISO standards, as applicable. Issues related to elevated particulate matter are sometimes found late in the development effort which can significantly impact timelines and budget; thus, leading to the cancelation of device development projects and even clinical trials. This presentation will examine a process that can be implemented to mitigate potential issues related to particulate matter prior to the significant investment in device development efforts. Insights will be provided on how to choose the appropriate delivery mechanism depending on drug product properties and best practices for choosing the right test method for measuring particulate counts. Archimedic is also an event sponsor at Combination Products Summit 2024, make sure to swing by their booth to say hello 👋 ! Register for Combination Products Summit: https://lnkd.in/eY8w4jNc #combinationproducts #usp #isostandards #particulatematter #drugproducts #drugdelivery #pharmaevent #conference
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VP Business Development at Evotec for contract API, drug product, preclinical development and integrated INDiGO IND packages inclusive of all three.
You've done lead optimization to find the right compound. You have demonstrated potency, selectivity and efficacy. There's just one problem. It isn't soluble enough to develop - you won't be able to achieve necessary concentrations in your tox studies and the formulation isn't suitable for the clinic. Please join us for a webinar where our experts present a real case study of developing a rescue formulation using minimal amounts of API.
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How to turn a poorly soluble drug into a high performing formulation in just six weeks with scarce API availability? Join experts Fabrizio Fina and Zsolt Lendvai as they present the case study of ID11916 and explain how, from its initial water-insoluble state, it was quickly transformed into an innovative oral formulation, accelerating its path to the human clinical trial phase. Learn more and register here- https://hubs.ly/Q02z4NDn0 #bioavailability #preformulation #earlyformulation #drugdevelopment
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Discover the "hard-rock" 😉 story of this compound in our new case study webinar with Fabrizio Fina, PhD and Zsolt Lendvai!
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Multimodalities Drug Development Catalyst - SVP Pharmaceutical Development Science & Strategy at Evotec
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How to turn a poorly soluble drug into a high performing formulation in just six weeks with scarce API availability? Join experts Fabrizio Fina and Zsolt Lendvai as they present the case study of ID11916 and explain how, from its initial water-insoluble state, it was quickly transformed into an innovative oral formulation, accelerating its path to the human clinical trial phase. Learn more and register here- https://hubs.ly/Q02z4NDn0 #bioavailability #preformulation #earlyformulation #drugdevelopment
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Senior Formulation Scientist I | PhD in Pharmaceutics at UCL | Oral Formulations and 3D Printing Expert | Pharmacist
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How to turn a poorly soluble drug into a high performing formulation in just six weeks with scarce API availability? Join experts Fabrizio Fina and Zsolt Lendvai as they present the case study of ID11916 and explain how, from its initial water-insoluble state, it was quickly transformed into an innovative oral formulation, accelerating its path to the human clinical trial phase. Learn more and register here- https://hubs.ly/Q02z4NDn0 #bioavailability #preformulation #earlyformulation #drugdevelopment
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