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Elsevier

Libros en Fabricación y Envasado de Medicamentos

  • Pharmaceutical QbD with Design of Experiments

    Statistical Tools and Applications in Drug Delivery Systems
    • 1 Edición
    • Khushwant Yadav
    • Inglés
    Pharmaceutical QbD with Design of Experiments: Statistical Tools and Applications in Drug Delivery Systems offers comprehensive coverage of best practices in pharmaceutical manufacturing. The first section discusses the principles and basics of Quality by Design (QbD). Part two covers the foundational statistical principles and tools for the Design of Experiments (DoE). Section three is dedicated to the applications of QbD for conventional formulations. The next section provides ample coverage of applications to Novel Drug Delivery Systems (NDDS), including micro and nano-particles. The final section discusses the application of QbD for the optimization of pharmaceutical processes and equipment.Researcher... in pharmaceutical manufacturing will benefit from this thorough statistical review, while students in this field will gain practical insights the experienced chapter authors provide in case studies. Industry professionals can find solutions to their particular problems within the insights and strategies shared in this book.

  • Advances in Tablet Manufacturing Technologies

    • 1 Edición
    • Honey Goel + 2 más
    • Inglés
    Advances in Tablet Manufacturing Technologies consolidates cutting-edge information on the latest technologies in tablet design and manufacturing, addressing the pressing need for innovation in an increasingly complex global market. The book is structured to provide a thorough understanding of tablet technology, beginning with foundational concepts and progressing through specialized topics. Key sections explore the historical context of tablet development, the significance of pharmaceutical excipients, preformulation aspects, and the physics of tablet compression. Subsequent chapters explore advanced topics, including coated tablets, modified-release formulations, organ-specific tablets, and state-of-the-art innovations like 3D printed tablets.Each chapter is enriched with practical examples and case studies, ensuring that readers can apply theoretical knowledge to real-world scenarios. With contributions from a diverse group of national and international experts, this book is an invaluable asset for scientists in academia and industry alike. It elucidates preformulation parameters, outlines regulatory frameworks, and discusses recent advances in excipient technology and in-process testing equipment.

  • Developing Solid Oral Dosage Forms

    Pharmaceutical Theory and Practice
    • 3 Edición
    • Yihong Qiu + 4 más
    • Inglés
    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 oral dosage form development, from discovery support through commercial manufacturing. This new edition features 13 new or rewritten chapters, along with significant updates to existing content, reflecting the latest advancements in the field, including new theories, scientific findings, approaches, techniques, modeling, and the emerging opportunities offered by AI.This book consists of 44 chapters covering in-depth principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their applications throughout the R&D process and commercial production of oral dosage forms. New chapters address topics such as absorption evaluation of oral dosage forms, formulation principles, and applications based on supersaturation, patient-centric product design, product design through the 505(b)(2) NDA pathway, design of experiments (DoE), process modeling, 3D printing, and machine learning applications in commercial manufacturing. Existing chapters have been updated or completely rewritten to provide advanced information and include practical case studies. Important topics such as amorphous solid dispersions, modified-release delivery, manufacturing technologies, modeling and simulation, fundamentals of dissolution and bioequivalence, IVIVC, biowaivers, regulatory frameworks, and many others are covered.The new edition of this book is an indispensable resource for industry professionals, academic institutions, and regulatory bodies seeking to stay current with advances in solid dosage form development and manufacturing. It offers a thorough understanding of fundamental principles and techniques, along with practical guidance on applying these concepts to real-world challenges.

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

    From Bench to the Clinics
    • 1 Edición
    • Neelam Poonia + 2 más
    • Inglés
    How to Develop Robust Scale-up Strategies for Complex Injectable Dosage Forms: From Bench to the Clinics provides a comprehensive roadmap for transitioning complex injectable formulations from the laboratory to clinical applications. Offering an exploration of various complex injectables, including liposomal dosage forms, nanoparticles, and microspheres, this book delves into dosage form design, excipient selection, stability studies, and optimization techniques. The book examines manufacturing technologies such as aseptic processing, sterile filtration, and lyophilization, and their applications in producing complex injectables. Discussions on quality control measures, analytical techniques, and quality assurance practices are provided to ensure consistent quality and purity 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. 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
    • 2 Edición
    • Ajit S. Narang + 1 más
    • Inglés
    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

    • 2 Edición
    • T.A. Sonia + 1 más
    • Inglés
    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

    • 1 Edición
    • Dimitrios A. Lamprou
    • Inglés
    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

    • 1 Edición
    • Dimitrios A. Lamprou + 1 más
    • Inglés
    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
    • 1 Edición
    • Bin Yu + 1 más
    • Inglés
    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

    • 1 Edición
    • Alberto Pais + 3 más
    • Inglés
    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.