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By Tom von Gunden, chief editor, Drug Delivery Leader
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Videocast guest Ken Greenberg of SonoThera discusses delivering gene therapy payloads to targeted indications. He describes how ultrasound-mediated, in vivo infusion of naked, or non-encapsulated, DNA to organ targets allows for larger cargo sizes than do vector-based approaches.
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Stability And Release Testing For Delivery Devices: Always Required?
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By Doug Mead, CP Pathways LLC
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Combination products consultant Doug Mead reports on precedent research on FDA waivers for functional stability and release testing for delivery devices. He provides sample scenarios related to Essential Performance Requirements (EPRs) and the more recent guidance on Essential Drug Delivery Outputs (EDDOs).
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The Importance Of Primary Containers In Drug Delivery
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Q&A | Grand River Aseptic Manufacturing
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Early collaboration and technical evaluation to select the right primary container materials prevent costly delays, ensuring specialized delivery systems reach patients efficiently and safely.
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