Authors
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iMRI-Guided Gene Therapy and Drug Delivery for CNS DisordersLeveraging real-time MRI guidance for intracranial gene therapy administration potentially improves efficacy and outcomes.
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Revolutionizing Biomanufacturing: The Digitalization AdvantageDigital transformation allows for smarter and connected biomanufacturing operations.
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Low Temperature Spray DryersExperts in solid dosage technology, offering electrostatic spray dryers, fluid bed systems, and other process solutions used daily to help the pharmaceutical, nutraceutical, food, fine chemical, and biopharmaceutical industries.
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ICH Q9: Attaining a Quality-Business Synergy through Quality Risk Management, ROI Analysis, and Highly Capable FacilitiesThis paper explores the relationship between investing in pharmaceutical manufacturing risk reduction and meeting business objectives.
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Handling HPAPIsThe manufacture of high potency active pharmaceutical ingredients (HPAPIs) is on the rise with R&D projects showing a continuing interest in these products.
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Phase-appropriate Analytical MethodologyA phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.
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Spectrophotometric Determination of LeadThe authors developed a reliable spectrophotometric method for determining and measuring trace amounts of lead in various samples.
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Artificial Intelligence in Pharmaceutical ManufacturingFDA is anticipating how AI may advance manufacturing and improve supply chain security.
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The Role of Dendrimers in Topical Drug DeliveryThis review provides an update of how dendrimer technology is being applied to the development of novel systems for various topical delivery applications.
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Assessment of Nanosuspension Formulation for Intranasal AdministrationResearch suggests that intranasal nanosuspensions offer a promising way to formulate and deliver drugs that are poorly soluble in water to patients with chronic conditions.
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Pharmaceutical Companies Can Optimize Enterprise Asset Management and Achieve SuccessAn integrated platform that keeps real-time data in a single location can be a major asset for pharmaceutical companies, as it saves time and money, leading to better quality products and higher profits.
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Easy Coloring for Liquid- and Solid-Dosage Drug Forms***Live: Tuesday, November 24, 2020 at 9am EST| 2pm GMT| 3pm CET*** Coloring as an aesthetic value for a product is becoming more important for pharmaceutical and nutritional products and helps differentiate between various grades of active ingredients. This webcast introduces the world of easy coloring, answers questions about pigments, pigment blends, and how to color solid- or liquid-dosage forms in an efficient way. Register for this webcast to learn how ready-to-use coloring systems can simplify production process.*** On demand available after final airing until Nov. 24, 2021.***
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Serialization: Reducing Counterfeit Drugs and Increasing SalesAn effective data structure and simple communication between production, logistics, and sales are essential for delivering this level of accountability, traceability, and security.
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Emerging Applications of Vitamin E TPGS in Drug DeliveryThe author discusses some new applications of TPGS in the pharmaceutical field that should see this versatile excipient retain its place in the drug formulators toolbox.
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High-Growth Microbial Fermentation for the Manufacture of BiologicsChallenges in fermentation can be addressed through equipment changes, facility design, and process development.
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Accelerating Project Delivery with a Lean Alternative to DBBLean delivery offers a promising solution to supply and manufacturing bottlenecks by integrating project teams early on and widening the team’s field of view.
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BioDuro is Redefining CRDMO Partnerships With End-to-End InnovationHow BioDuro is expanding its global CRDMO footprint by improving integrated capabilities and delivering high-quality, end-to-end solutions for drug development and manufacturing
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Elaboration, Expansion, and Evolution in Outsourcing of Clinical ResearchThe rising complexity of clinical research protocols has necessarily expanded the CRO landscape.
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Untethered Data: Unifying and Contextualizing Drug Discovery DataCapturing and curating R&D data are crucial to realizing the full value of advanced analytics.
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Designing and Delivering Therapeutic ProteinsAn updated book summarizes recent research for formulators and drug-delivery specialists.
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Elicitation of Expert Knowledge and Probabilities for Controlling Subjectivity in Risk-Based Decision MakingMore attention should be given to how expert opinions and judgments are elicited for reducing uncertainty in quality risk management and risk-based decision making.
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Protecting Intellectual Property for COVID-19 InnovationsOpposition to IP protection for COVID-19 vaccines, therapies, tests and other technologies may only prevent eradication and treatment of the disease.
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A Harmonized Approach to Performing a Risk-Based Audit Trail ReviewThe IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.
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The Relevance and Readiness of AI for GMP Manufacturing: An Industry PerspectiveLeverage artificial intelligence (AI) for a more streamlined GMP manufacturing process.
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Beyond GenAI: The Training-Free Discovery Potential of LLMs in a Drug Safety and Regulatory ContextLife sciences data sets can be vast and complex to process, but up to now bringing intelligent automation systems up to speed and validating them has felt debilitatingly onerous. Large language models tackle these barriers head on. Ramesh Ramani and RaviKanth Valigari, technology innovators at ArisGlobal, explain.
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EGA Position On The EC's Proposal For A Falisifed Medicines DirectiveAlthough the European Generic medicines Association (EGA) n has welcomed the European Commission's proposal for a Directive on the falsification of medicines, it has also identified subjects that are of specific relevance to the European generic medicines industry.
