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Drug Delivery LeaderDrug Delivery LeaderDrug Delivery Leader Get more Drug Delivery Leader insight with our FREE newsletter sign me up Log In or Subscribe Injectable Oral Inhalation Transdermal Infusion Ocular Listen & Watch Drug Delivery Leader Live Sit and Deliver Supplier Horizons Preparing For The FDA QMSR: Will You Be Ready? The new FDA Quality Management System Regulation (QMSR) becomes effective in February 2026. In this article, Fran DeGrazio discusses the implications for combination product and medical device developers as they prepare to demonstrate QMSR compliance. Drug Product Formulation & Process Development: The Must-Have Skills At A Glance FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA) Bacterial Endotoxin Testing, Part 4: Key Tests For Endotoxin Detection Takeda Cut Its PPQ Timeline With beePFS — Here's How Bacterial Endotoxin Testing, Part 3: Calculating Endotoxin Limits & MVD Setting The Bar For Drug Product Quality, Part 2: The Evolving Practice Of Particle Testing Setting The Bar For Drug Product Quality, Part 1: How Best Practices Prevail Bacterial Endotoxin Testing, Part 2: Prerequisites & Reagent Preparation Bacterial Endotoxin Testing, Part 1: Overview Embrace Packaging and Delivery Systems Designed for Today's Standards More Featured Editorial ON-DEMAND WEBINARS Identify And Mitigate Absorption Risks With PBPK Modeling See how PBPK models combined with custom and off-the-shelf in vitro tools and solubility enhancement expertise can reduce the need for drug product reformulation or repeated preclinical or clinical studies. Formulation Of Crystalline Nanoparticles Enabling Superior Drug Load Explore how bioavailability of poorly soluble APIs can be improved and patient compliance enhanced by reducing the size or number of tablets that a patient must take to achieve the required dose. Challenges Associated With In-Use Simulated Administration Of Biologics Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues. Dramatic Reduction Of Solvent Usage In Pharmaceutical Spray Drying Using volatile processing aids to increase drug solubility in more environmentally friendly solvents, like methanol, reduces the amount of solvent required to manufacture amorphous solid dispersions (ASDs). More Webinars ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS Supporting The Unique Needs Of Your Sterile Injectable Leveraging the experience and specialized technology of a reliable CDMO partner is essential to ensure your sterile injectable therapeutic's safety and quality while delivering at speed. Semi-Solid And Semi-Liquid Dosage Forms: What To Know Interest in semi-solid dose (SSD) forms has been on the rise. Learn more about the advantages of formulating medications into SSD forms as well as the challenges to consider. Single Source Partner: Seamless Approach To Deliver World-Class Treatment Growing demand for high-value, complex therapies requires the right containment and delivery systems: solutions that offer superior quality and patient comfort while meeting stringent regulatory requirements.  Partnering For Success In Sustained Drug Delivery Formulations With a focus on the sustained and controlled drug delivery segment of the pharmaceutical market, learn about technology platforms, support services, and sustainable solutions. Understanding Of Amorphous Solid Dispersions & Their Downstream Development Understanding the properties of ASDs and their relationship to the downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs. Inspection Of Injectable Products For Visible Particulates Examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables. Improve Solubility And Spray Drying Throughput For Brick Dust Compounds This paper presents three approaches to address poor solubility in organic solvents for spray drying as well as case studies outlining their successful application during development. Sterile Injectable Therapies: Revolutionizing Lifecycle Management The right balance of technical understanding, logistics, regulatory guidelines, and knowledge about product stability and quality is crucial for capitalizing on the benefits of shifting delivery formats. A New Framework For Identifying Nitrosamine Risks And Efficiently Derisking Products Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance. Using Advanced Technologies To Formulate Complex Molecules In this survey, 200+ people involved in the oral dose market shared their views on barriers to the development of oral formulations and technological responses to them. More Articles, App Notes, Case Studies, & White Papers Get the latest articles from Drug Delivery Leader delivered to your inbox. I agree to the Terms. I agree to the Privacy Statement. SIGN ME UP Tom ensures that Drug Delivery Leader provides you with indispensable resources for staying current on the industry’s most innovative thinking. Get in touch today! In her new column, Fran offers keen industry insights exclusively on Drug Delivery Leader. FRANKLY FRAN Preparing For The FDA QMSR: Will You Be Ready? The new FDA Quality Management System Regulation (QMSR) becomes effective in February 2026. In this article, Fran DeGrazio discusses the implications for combination product and medical device developers as they prepare to demonstrate QMSR compliance. Setting The Bar For Drug Product Quality, Part 2: The Evolving Practice Of Particle Testing Setting The Bar For Drug Product Quality, Part 1: How Best Practices Prevail Embrace Packaging and Delivery Systems Designed for Today's Standards The Key to Regulatory Innovation? Global Harmonization Organizational Imperatives For Combination Product Development FREE EBOOK: COMBINATION PRODUCTS Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval. FEATURED PRODUCTS & SERVICES Injection Molding Single Dose Blow/Fill/Seal Pharmaceutical Vials A User-Friendly Solution For Fill-Finish Professionals Standard And Custom Valve Solutions Small, Simple-To-Use Package For Delivering High-Viscosity Formulations Pharmaceutical Vial Filling Machine With Isolator Pharmaceutical Aseptic Filling Equipment Controlled Expansion Of Supercritical Solutions (CESS®) Technology Blow-Fill-Seal Packaging Systems For Large Volume Nebulizers And Humidifiers Sterile Formulation Development More Products & Services NEWS Global CDMO Brings Technological Advancements & Significant Capacity To Ocean County, NJ Location Singota Solutions Announces -40 °C Pallet Storage Offering In EU Shapiro Administration Invests Nearly $3 Million To Bring Adare Pharma Solutions' Headquarters To Pennsylvania, Creating 115 New, Well-Paying Jobs In Philadelphia Battelle Prepares To Guide Medical Device Companies Through New Federal, State And International Regulations On "Forever Chemicals" Enable Injections Names New Chief Commercial Officer To Leadership Team InvestING In Pharmaceutics And Manufacturing Capabilities Lifecore Biomedical Concludes Strategic Evaluation Process, Announces Management Succession And Board Changes SMC Ltd. Announces Expansion Of Sterile Fill Finish Capabilities, Unveiling State-Of-The-Art Facility In North Carolina SGD Pharma Successfully Trials Hydrogen Burners At Its Saint-Quentin-Lamotte (SQLM) Plant To Accelerate Its Ambitious Decarbonization Roadmap Bringing Engineering, Clinical Study Expertise To A New Collaboration More News This website uses cookies to ensure you get the best experience on our website. Learn more Got it! Partner With Us Request More Information Subscribe Newsletter Follow Us on LinkedIn Life Science Connect Advancing RNA Bioprocess Online Biosimilar Development Cell & Gene Clinical Leader Clinical Supply Leader Clinical Tech Leader Drug Discovery Online Med Device Online Laboratory Network Life Science Leader Outsourced Pharma Pharmaceutical Online Editorial Archived Newsletters Article Reprints Editorial Submission Guidelines Events CMO Leadership Awards CRO Leadership Awards Learn More About Us Contact Us Work For Us Copyright © 1996-2024 VertMarkets, Inc. 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