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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.

  • 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.

  • Biocontamination Control for Pharmaceuticals and Healthcare

    • 2 Edición
    • Tim Sandle
    • Inglés
    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
    • 2 Edición
    • Jelena Duris
    • Inglés
    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.

  • Clinical Case Studies on Medication Safety

    • 1 Edición
    • Yaser Mohammed Al-Worafi
    • Inglés
    Clinical Case Studies on Medication Safety provides real and simulated scenarios about safety issues related to medication, including Adverse Drug Reactions (ADRs), medication errors, and Drug Related Problems (DRPs). The book explains real-life case management, including details about adverse drug reactions, mistakes during drug administration, drug avoidance, and drug-drug interactions with a goal of improving patient care. With over 150 case studies, including cases from alternative medicine and traditional medicine, this book will help medical and health sciences educators, students, healthcare professionals, and other readers apply their knowledge and skills to solve cases for better patient care.

  • Alginates in Drug Delivery

    • 1 Edición
    • Amit Kumar Nayak + 1 más
    • Inglés
    Alginates in Drug Delivery explores the vital precepts, basic and fundamental aspects of alginates in pharmaceutical sciences, biopharmacology, and in the biotechnology industry. The use of natural polymers in healthcare applications over synthetic polymers is becoming more prevalent due to natural polymers’ biocompatibility, biodegradability, economic extraction and ready availability. To fully utilize and harness the potential of alginates, this book presents a thorough understanding of the synthesis, purification, and characterization of alginates and their derivative. This book collects, in a single volume, all relevant information on alginates in health care, including recent advances in the field. This is a highly useful resource for pharmaceutical scientists, health care professionals and regulatory scientists actively involved in the pharmaceutical product and process development of natural polymer containing drug delivery, as well as postgraduate students and postdoctoral research fellows in pharmaceutical sciences.

  • How to Integrate Quality by Efficient Design (QbED) in Product Development

    • 1 Edición
    • Bhavishya Mittal
    • Inglés
    The development of a robust drug product requires juggling many competing priorities such as overcoming scientific challenges, following regulatory requirements, and managing business-related concerns. Unfortunately, despite large resources spent on R&D, multifactor productivity of pharmaceuticals is on the decline for several years now. Because of this business reality, pharmaceutical companies have seen a notable change in the traditional operating model and footprint over the past couple of decades. Outsourcing, in particular, has emerged as a successful business model for many pharmaceutical companies looking for ways to strategically increase their R&D capabilities and to augment their in-house resources. How to Integrate Quality by Efficient Design (QbED) in Product Development bridges the gap between theory and practice when it comes to strategic decision-making in a pharmaceutical research scenario. This book will introduce the concept of QbED and focus on various aspects such as patient-centric product designs, platform-based manufacturing technologies, business acuity, and regulatory strategies to balance the challenges in outsourcing with the need for strategic and statistically sound experiments rooted in good science. Detailed discussions will cover pharmaceutical business models, regulatory approval process, quality by design (QbD), business analytics, and manufacturing excellence specifically for small molecules and solid oral dosage forms. With the addition of case studies, flowcharts, diagrams, and data visualizations, How to Integrate Quality by Efficient Design (QbED) in Product Development will be a practical reference to help professionals working in the area of pharmaceutical drug development, strategy, and outsourcing management.

  • High-Throughput Formulation Development of Biopharmaceuticals

    Practical Guide to Methods and Applications
    • 1 Edición
    • Vladimir I. Razinkov + 1 más
    • Inglés
    High Throughput Formulation Development of Biopharmaceuticals: Practical Guide to Methods and Applications provides the latest developments and information on the science of stable and safe drug product formulations, presenting a comprehensive review and detailed description of modern methodologies in the field of formulation development, a process starting with candidate and pre-formulation screening in its early development phase and then progressing to the refinement of robust formulations during commercialization in the later phases of development. The title covers topics such as experiment design, automation of sample preparation and measurements, high-throughput analytics, stress-inducing methods, statistical analysis of large amounts of formulation study data, emerging technologies, and the presentation of several case studies, along with a concluding summary.

  • Design and Manufacture of Pharmaceutical Tablets

    • 1 Edición
    • Reynir Eyjolfsson
    • Inglés
    Design and Manufacture of Pharmaceutical Tablets offers real world solutions and outcomes of formulation and processing challenges of pharmaceutical tablets. This book includes numerous practical examples related to actual formulations that have been validated and marketed and covers important data in the areas of stability, dissolution, bioavailibity and processing. It provides important background and theoretical information on design and manufacturing and includes a full section dedicated to design experimental methodology and statistics. In addition, this book offers a a general discussion of excipients used in proper tablet design along with practical examples related to excipients. Drug development scientists in industry and academia, as well as students in the pharmaceutical sciences will greatly benefit from the practical knowledge and case examples provided throughout this book.

  • Predictive Modeling of Pharmaceutical Unit Operations

    • 1 Edición
    • Preetanshu Pandey + 1 más
    • Inglés
    The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Qualityby Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included.

  • Orphan Drugs

    Understanding the Rare Disease Market and its Dynamics
    • 1 Edición
    • Elizabeth Hernberg-Ståhl + 1 más
    • Inglés
    This authoritative and comprehensive book makes the reader familiar with the processes of bringing orphan drugs to the global market. There are between 5,000 and 7,000 rare diseases and the number of patients suffering from them is estimated to be more than 50 million in the US and Europe. Before the orphan drug legislation enacted in the US in 1983, there was a limited interest from industry to develop treatment for very small patient groups. One of the difficulties is, of course, that similar levels of investment are needed from a pharmaceutical company to bring a drug to the market for both small and large patient groups.The journey from application of an orphan drug designation to a reimbursed market- approved drug is long and many obstacles occur during the journey.After reading the book, readers will: Understand who the players/stakeholders are in the rare orphan disease field and their specific needs and concerns: patients and patient organizations, researchers and treating physicians within the field, industry, regulatory and reimbursement bodies* Understand the strong partnership between the different players and the various initiatives to improve and increase access to treatment for patients; minimizing the gap between numbers of known diseases, orphan designations, approved drugs and paid drugs.The book also provides short practical case stories from patients and researchers, as well as representatives from industry and authorities on the challenges they came across in developing orphan drugs or getting access to orphan drugs.

  • Formulation Tools for Pharmaceutical Development

    • 1 Edición
    • J E Aguilar
    • Inglés
    A range of new and innovative tools used for preformulation and formulation of medicines help optimize pharmaceutical development projects. Such tools also assist with the performance evaluation of the pharmaceutical process, allowing any potential gaps to be identified. These tools can be applied in both basic research and industrial environment. Formulation tools for pharmaceutical development considers these key research and industrial tools.Nine chapters by leading contributors cover: Artificial neural networks technology to model, understand, and optimize drug formulations; ME_expert 2.0: a heuristic decision support system for microemulsions formulation development; Expert system for the development and formulation of push-pull osmotic pump tablets containing poorly water-soluble drugs; SeDeM Diagram: an expert system for preformulation, characterization and optimization of tables obtained by direct compression; New SeDeM-ODT expert system: an expert system for formulation of orodispersible tablets obtained by direct compression; and 3D-cellular automata in computer-aided design of pharmaceutical formulations: mathematical concept and F-CAD software.

  • The Path from Biomarker Discovery to Regulatory Qualification

    • 1 Edición
    • Federico Goodsaid + 1 más
    • Inglés
    The Path from Biomarker Discovery to Regulatory Qualification is a unique guide that focuses on biomarker qualification, its history and current regulatory settings in both the US and abroad. This multi-contributed book provides a detailed look at the next step to developing biomarkers for clinical use and covers overall concepts, challenges, strategies and solutions based on the experiences of regulatory authorities and scientists. Members of the regulatory, pharmaceutical and biomarker development communities will benefit the most from using this book—it is a complete and practical guide to biomarker qualification, providing valuable insight to an ever-evolving and important area of regulatory science. For complimentary access to chapter 13, 'Classic' Biomarkers of Liver Injury, by John R. Senior, Associate Director for Science, Food and Drug Administration, Silver Spring, Maryland, USA, please visit the following site: http://tinyurl.com/C...

  • Inhaler Devices

    Fundamentals, Design and Drug Delivery
    • 1 Edición
    • Polina Prokopovich
    • Inglés
    Given their direct impact on the health and quality of life for millions, inhalers represent a major turning point in the history of modern medicine. Inhaler devices: Fundamentals, design and drug delivery provides readers with an introduction to the fundamentals of inhaler technology, with a comprehensive discussion of the history of inhalers as well as a discussion on current research and development.Part one discusses the fundamentals and development of inhaler devices as well as drug formulations for inhalers. The treatment of asthma is also discussed. Part two reviews recent developments in drug formulation and nanotechnology for inhaler devices, emerging inhaler technology and possible future trends.Inhaler devices: Fundamentals, design and drug delivery is an essential design guide for good industrial practice, and will be an invaluable resource for those researching and treating conditions such as asthma; and those developing and manufacturing inhalation devices.

  • Contract Research and Manufacturing Services (CRAMS) in India

    The Business, Legal, Regulatory and Tax Environment in the Pharmaceutical and Biotechnology Sectors
    • 1 Edición
    • Milind Antani + 1 más
    • Inglés
    The field of contract research and manufacturing broadly encompasses those services in the pharmaceutical and biotechnology sectors that require extensive research and development and large-scale manufacturing facilities. The field has great potential for growth in the Indian outsourcing industry, which is world-renowned for its provision of cheap and highly-skilled services. Contract research and manufacturing services (CRAMS) in India provides a detailed account of the current scenario in India and the advantages that the Indian outsourcing industry can offer in the field of CRAMS. Following an overview of the services and their emergence in India, chapters in the book begin by discussing the legal and regulatory scenario and major concerns and issues. In the latter part of the book, topics covered include service agreements, dispute resolution and contract negotiations, followed by a discussion of the outlook for CRAMS in India and some concluding remarks. Several appendices are included, offering a list of major players in the field and various forms for use in licence applications.

  • Therapeutic Protein Drug Products

    Practical Approaches to formulation in the Laboratory, Manufacturing, and the Clinic
    • 1 Edición
    • Brian K Meyer
    • Inglés
    Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. A brief section on biophysical and analytical analysis is also provided. Properties of therapeutic protein formulations are described and include opalescence, phase separation, color, and subvisible particles. An emphasis is placed on material and process testing to ensure success during manufacturing. The drug product manufacturing process, which includes the process of compounding to filling, is also covered. Methods of delivery in the clinic are addressed, as well as delivery strategies. Finally, a perspective on the regulatory requirements for therapeutic protein formulations is discussed.