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Books in Drug manufacturing and packaging

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    • Developing Solid Oral Dosage Forms

      Pharmaceutical Theory and Practice
      • 3rd Edition
      • Yihong Qiu + 4 more
      • English
      Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Third Edition is a comprehensive and up-to-date guide for professionals and academics engaged in all aspects of the development process of oral dosage forms. This new edition reflects the significant impact of AI and ML on pharmaceutical science in recent years, with six new chapters and extensive updates to existing content. The book covers essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, as well as their application to the research and development process of oral dosage forms. The Third Edition features new chapters on Evaluation of Drug Absorption from Oral Dosage Forms, Dissolution Evaluation of Enabling Formulations Based on Supersaturation, Patient-Centric Drug Product Design, and Design of Improved and Differentiated Products through 505(b)(2) NDA Pathway. Additionally, existing chapters have been updated, combined, or completely rewritten to provide a well-organized and valuable reference. Topics such as spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-release dosage forms, biowaivers, and more are covered in this edition. Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Third Edition is an indispensable resource for industry professionals and academics looking to stay current with the latest advancements in solid formulation development. This book not only provides a thorough understanding of the principles and techniques involved in the development process but also offers practical guidance on how to apply these concepts to real-world situations. With its extensive coverage of new topics and updates to existing chapters, this edition is an essential tool for those working in the field of pharmaceutical science.

    • How to Develop Robust Scale-up Strategies for Complex Injectable Dosage Forms

      From Bench to the Clinics
      • 1st Edition
      • Neelam Poonia + 2 more
      • English
      How to Develop Robust Scale-up Strategies for Complex Injectable Dosage Forms: From Bench to the Clinics is an essential guide providing a comprehensive roadmap for transitioning complex injectable formulations from the laboratory to clinical applications. Offering an in-depth exploration of various complex injectables, including liposomal dosage forms, nanoparticles, and microspheres, this book delves into the principles of dosage form design, excipient selection, stability studies, and optimization techniques. Readers will gain valuable insights into ensuring the stability, efficacy, and safety of injectables during the scale-up process, as well as strategies for maintaining product quality and consistency from lab-scale to commercial-scale production. The book thoroughly examines manufacturing technologies such as aseptic processing, sterile filtration, and lyophilization, and their applications in producing complex injectables. Detailed discussions on quality control measures, analytical techniques, and quality assurance practices are provided to ensure the consistent quality and purity of injectables throughout the manufacturing process. Readers will benefit from the expert knowledge and practical insights shared by industry professionals and leading researchers, including successful examples of marketed complex injectables. Highlighting best practices and regulatory requirements, this book offers a comprehensive overview of the guidelines for the development, manufacturing, and commercialization of complex injectables. Discussions on Good Manufacturing Practices (GMP) and regulatory submissions underscore the importance of compliance in achieving successful product development. Ideal for pharmaceutical scientists, formulation developers, and regulatory professionals, this book is a valuable resource for anyone involved in the scale-up and commercialization of complex injectable dosage forms.

    • Handbook of Pharmaceutical Wet Granulation

      Theory and Practice in a Quality by Design Paradigm
      • 2nd Edition
      • Ajit S. Narang + 1 more
      • English
      Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm, Second Edition offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. This completely revised and updated edition features five new chapters covering new AI tools applied to scaling up granulation processes, model drive design, machine learning models for granule property prediction, design and scale up of fluid bed granulation, and process analytical methods. This book is the prefect reference for pharmaceutical manufacturing professionals. Academic researchers will benefit from the practical advice provided by the editors and chapter authors.

    • Oral Delivery of Insulin

      • 2nd Edition
      • T.A. Sonia + 1 more
      • English
      Oral delivery of Insulin, Second Edition is a complete reference on non-invasive insulin delivery systems, focusing on the prospect of oral delivery of peptides. The chapters in the revised edition present a comprehensive evaluation of the insulin therapy approaches, with an emphasis on insulin delivery strategies and current advances in engineered insulin delivery systems such as nano/microcarriers and hydrogels. Chapters provides an overview of diabetes mellitus, cover technological innovations, explore artificial intelligence and machine learning approaches to manage diabetes, explore a wide range of non-invasive and alternative routes of insulin administration, and much more.Other chapters cover challenges and strategies in oral insulin delivery, the experimental techniques used to develop oral insulin carriers, the use of polymeric nano and microparticles for insulin delivery, and the use of lipids and inorganic nanoparticles in insulin delivery. The final chapter provide an overview of current clinical trials on insulin delivery and future perspectives in the area. Clinicians can benefit from this information to develop a clear understanding about the research carried out worldwide in the field of oral delivery of insulin, including those in the clinical phase.

    • Sustainability in the Manufacturing of Pharmaceuticals

      • 1st Edition
      • Dimitrios A. Lamprou
      • English
      Sustainability in Pharmaceutical Manufacturing is a groundbreaking reference for the pharmaceutical industry. Currently lagging behind other manufacturing sectors, pharmaceutical production requires significant changes in areas such as manufacturing methods, waste management, packaging, and supply chain. This book compiles cutting-edge research from leading global experts, offering scientific insights and innovative strategies to revolutionize sustainability in pharmaceuticals. It explores the transformative potential of the circular economy, lifecycle management, and resource optimization for maximum efficiency and minimal environmental impact.The book delves into green chemistry, highlighting alternative solvents and methods for drug production. It emphasizes novel microfluidic and additive manufacturing techniques, utilizing bio-based sustainable polymers and materials. Chapters on greener drug discovery, development, and scaling processes provide the most current research at each production stage. This invaluable resource enables researchers in academia and industry to make informed choices, enhancing their manufacturing practices and shaping the future of sustainability in the pharmaceutical sector.

    • Fundamentals and Future Trends of 3D Printing in Drug Delivery

      • 1st Edition
      • Dimitrios A. Lamprou + 1 more
      • English
      Fundamentals and Future Trends of 3D Printing in Drug Delivery provides readers with all needed information for their journey from ideation to approval of innovative drug delivery devices produced through additive manufacturing.This book provides an in-depth discussion on key factors affecting the printing process such as different printer technologies, materials selection, resolutions, temperatures and speeds. Dedicated chapters include specific drug delivery devices in the form of oral solid dosage, implants, catheters and vascular grafts, and microneedles. The prospects of 3D printing associated with personalized medicine are covered in a full chapter.Fundamentals and Future Trends of 3D Printing in Drug Delivery is the perfect reference for any researcher or professional embarking on a 3D printing process for drug delivery devices. The regulatory aspects included are of particular interest to companies entering this promising market.

    • Drug Discovery Stories

      From Bench to Bedside
      • 1st Edition
      • Bin Yu + 1 more
      • English
      Drug Discovery Stories: From Bench to Bedside presents a collection of cases on the development of highly successful pharmaceuticals. It delves into the realm of drug discovery, exploring the structural biology and biological functions of the sought-after targets. The book covers the identification of promising compounds, their transformation from hits to leads through meticulous optimization, and the elucidation of how key compounds interact with the target (in essence, providing invaluable insights for drug design). Additionally, it covers essential information such as the pivotal biological and PK data of lead compounds, any noteworthy clinical results, and a comprehensive overview of other candidate compounds.The field of drug discovery and development has experienced rapid evolution, with numerous new drugs receiving approval each year. While several books have been published on this subject, there is a pressing need for a new book series that accurately reflects the current advancements in drug discovery. This book aims to not only cater to the drug discovery community but also engage other communities involved in chemical biology, synthetic chemistry, and pharmacology.

    • Artificial Intelligence for Drug Product Lifecycle Applications

      • 1st Edition
      • Alberto Pais + 3 more
      • English
      Artificial Intelligence for Drug Product Lifecycle Applications explains the use of artificial intelligence (AI) in drug discovery and development paths, including the clinical and postapproval phases. This book gives methods for each of the drug development steps, from the fundamentals to postapproval drug product. AI is a synergistic assembly of enhanced optimization strategies with particular applications in pharmaceutical development and advanced tools for promoting cost-effectiveness throughout the drug lifecycle. Specifically, AI brings together the potential to improve drug approval rates, reduce development costs, get medications to patients faster, and help patients comply with their treatments.Accelerat... pharmaceutical development and drug product approval rates will enable larger profits from patent-protected market exclusivity. This book offers the tools and knowledge to create the right AI strategy to extend the landscape of AI applications across the drug lifecycle. It is especially useful for pharmaceutical scientists, health care professionals, and regulatory scientists, as well as advanced students and postgraduates actively involved in pharmaceutical product and process development involving the use of artificial intelligence in drug delivery applications.

    • Biocontamination Control for Pharmaceuticals and Healthcare

      • 2nd Edition
      • Tim Sandle
      • English
      Biocontamination Control for Pharmaceuticals and Healthcare, Second Edition outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covers many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141), this new edition expands coverage of quality risk management and contains completely new examples to help professionals bridge the gap between regulation and implementation. This book offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy.

    • Computer-Aided Applications in Pharmaceutical Technology

      Delivery Systems, Dosage Forms, and Pharmaceutical Unit Operations
      • 2nd Edition
      • Jelena Duris
      • English
      Computer-Aided Applications in Pharmaceutical Technology: Delivery Systems, Dosage Forms, and Pharmaceutical Unit Operations, Second Edition covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with an emphasis on their applications in process control, neural computing, data science, computer-aided biopharmaceutical characterization, as well as the application of computational fluid dynamics in pharmaceutical technology. Completely updated, the book introduces the theory and practice of computational tools through new case studies. Chapters cover Quality by Design in pharmaceutical development, overview data mining methodologies, present computer-aided formulation development, cover experimental design applications, and much more.