Infusion Drug Delivery Articles
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Transendocardial Cell Delivery In Post‑Acute Myocardial Infarction
5/4/2026
Optimized delivery technologies will be central to next-generation therapies, serving as key differentiators for both clinical efficacy and operational feasibility.
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BCS Class IV: Rescuing Hard To Deliver Molecules With Nanoformulation
4/23/2026
BCS Class IV drugs have low solubility and permeability. Oral nanoparticles can overcome both barriers, offering a more effective and tunable oral delivery strategy.
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Patient-Centric Drug Delivery: Do Possible And Preferable Always Align?
4/22/2026
In this article, Chief Editor Tom von Gunden discusses the alignment of drug delivery method with patient preference and need. He reflects on recent conversations in which he heard from experts in drug and delivery product development, as well as patients themselves, about patient-centric considerations such as safety, efficacy, usability, and convenience. The primary use case is the transition from clinically administered IV to subcutaneous injection, including self-administration.
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AI, Digitalization, And In Vivo Programming Redefine Cell And Gene Therapy
4/20/2026
By merging precision genetic engineering with the scalability of nanomedicine and the predictive power of AI, scientists are reshaping the future of human health.
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Nanosystems And Rare Diseases: Opportunities And Limitations
3/27/2026
Nanosystems offer unique capabilities, enabling researchers to design precise, versatile delivery systems that address key challenges in rare diseases.
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Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables
3/17/2026
A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.
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The Future Of Kidney Disease Therapeutics: Bringing Nanomedicine To Nephrology
3/6/2026
Nanomedicines are solving the drug delivery problem in kidney disease. The next step: bridging the translational gap to advance these technologies into the clinic.
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The Advantages Of Antibodies Over Ligands In The Alpha Emitter Era
3/5/2026
The alpha era in radiopharmaceuticals is still being defined. The choices developers make now about delivery platforms will shape individual programs and the trajectory of the field.
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GenAI: The Muscle Behind Strong Regulatory Intelligence For Combination Products
3/2/2026
In this article, combination product consultant Doug Mead provides the rationale and offers guidance for using GenAI tools to search regulatory databases. He shows the benefits for biopharma developers of conducting “precedent research” into previous regulatory pathways and results for similar or related drug delivery product submissions.
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Regulatory Precedents For Drug Delivery: Uncovering Clues To Successful Submissions
3/2/2026
In this article, Chief Editor Tom von Gunden considers the need for and benefit of conducting AI-based research into regulatory precedents for drug delivery submissions and approvals. He consults combination products consultant Doug Mead on best practices in bolstering regulatory intelligence and regulatory approval success by way of advanced search methods.