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Elsevier

Libros en Ciencias Farmacéuticas

  • 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.

  • Natural Polysaccharides in Drug Delivery and Biomedical Applications

    • 1 Edición
    • Md Saquib Hasnain + 1 más
    • Inglés
    Natural Polysaccharides in Drug Delivery and Biomedical Applications provides a fundamental overview of natural polysaccharides, their sources, extraction methodologies, and characterizations. It covers specific natural polysaccharides and their effective application in drug delivery and biomedical use. Additionally, chapters in the book discuss key topics including the sources and extraction methodologies of natural polysaccharides, their role in tissue engineering applications, polysaccharide-based nanoparticles in biomedical applications, and their role in the delivery of anticancer drugs. Written by industry leaders and edited by experts, this book emphasizes recent advances made in the field.Natural Polysaccharides in Drug Delivery and Biomedical Applications provides academics, researchers, and pharmaceutical health care professionals with a comprehensive book on polysaccharides in pharmaceutical delivery process.

  • Mosby’s Pharmacy Technician Exam Review

    • 4 Edición
    • James J. Mizner
    • Inglés
    Prepare for success on your certification exam! Mosby's Pharmacy Technician Exam Review, 4th Edition provides a complete review of core knowledge, thousands of review questions, and nine practice exams – plus a custom online engine that allows for unlimited opportunities to practice specific topics or create unique simulated exams. A bulleted, outline format makes review easier, reinforcing understanding with full-color illustrations, photographs, and summary tables. All questions reflect the latest exam blueprints. This resource provides you comprehensive support every step of the way for entry-level or sterile compounding certification.

  • Polymeric Nanoparticles as a Promising Tool for Anti-cancer Therapeutics

    • 1 Edición
    • Prashant Kesharwani + 2 más
    • Inglés
    Polymeric Nanoparticles as Promising Tool for Anti-cancer Therapeutics provides an understanding of polymeric compounds and their use in cancer therapies. The book begins by giving an overview of the current status, future challenges and potential utilization of polymeric nanoparticles. It then covers specific polymeric nanoparticles through contributions from world-renowned experts and researchers. Chapters examine specific polymeric nanoparticles, their development as potential targeted delivery systems, and cancer characteristics that can be targeted for therapy development. The book synthesizes current research trends in the field, thus enhancing existing knowledge of nanomedicine, drug delivery and therapeutic intervention strategies in human cancers. Users will find this to be an ideal reference for research scientists and those in the pharmaceutical and medical fields who are working to develop novel cancer therapies using nanoparticle-based delivery systems.

  • Equipment Qualification in the Pharmaceutical Industry

    • 1 Edición
    • Steven Ostrove
    • Inglés
    Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems. Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols.

  • Biomarkers, Diagnostics and Precision Medicine in the Drug Industry

    Critical Challenges, Limitations and Roadmaps for the Best Practices
    • 1 Edición
    • Abdel Halim
    • Inglés
    The high failure rate in the pharmaceutical industry has positioned biomarkers and personalized medicine in the frontline, as possible solutions. If executed right, biomarkers and companion diagnostics (CDx) can potentially help the drug industry enhance the probability of success, accelerate the time to market, and, more importantly, benefit patients by supporting accurate diagnosis and selection of the most effective and least toxic therapies. This book aims to examine the challenges and limitations in biomarkers and laboratory tests. It also offers advice on best practices to ensure proper application of biomarkers and bridges the gap between diagnostic business development claims and real-life deliverables. The book covers biomarkers for different purposes, provides examples from different technologies, which includes standard-of-care approved assays as well as for-investigational-... and for-research-use-onl... assays. It also includes new data for biomarkers in different therapeutic indications and offers case studies and practical examples. This book serves as a reference to drug developers, IVD providers, clinical labs, healthcare givers, academicians, and researchers for best practices to help increase the probability of success in drug development and improve patient management.

  • The Core Model

    A Collaborative Paradigm for the Pharmaceutical Industry and Global Health Care
    • 1 Edición
    • Ibis Sanchez Serrano
    • Inglés
    The Core Model: A Collaborative Paradigm for the Pharmaceutical Industry and Global Health Care develops the innovative core model, an organizational research and design paradigm and economic theory that proposes a collaborative approach to resolving global health issues and improving the productivity of drug development. The model proposes that scientific collaboration does not occur in an unstructured manner, but actually takes place within a highly structured order where knowledge is transferred, integrated and finally translated into commercial products. An understanding of this model will help solve the global pharmaceutical industry´s productivity problems and address important global health care and economic issues. This book is useful to researchers, advanced students, regulators, and management in pharmaceutical industries, as well as healthcare professionals, those working in health economics, and those interested in scientific innovation processes.

  • NETosis

    Immunity, Pathogenesis and Therapeutics
    • 1 Edición
    • Geeta Rai
    • Inglés
    NETosis: Immunity, Pathogenesis and Therapeutics takes a focused approach to the clinical aspects of NETosis and drug development, bringing critical findings. Chapters introduce NETosis, consider mechanisms and antimicrobial strategies regulating NETosis, examine NETosis in neonates, explore the role of NETosis in autoimmunity, delve into NETosis and other diseases, and present therapeutic approaches for dysregulated NETosis. Since Brinkamm, et al, discovered an unrecognized neutrophil anti-microbial mechanism responsible for the extracellular killing of invading pathogens in 2004, the novel process in which nuclear chromatin de-condenses and DNA is ejected into the extra cellular environment, trapping and inactivating tissue pathogens has rapidly evolved.

  • Biomaterials and Bionanotechnology

    • 1 Edición
    • Inglés
    Biomaterials and Bionanotechnology examines the current state of the field within pharmaceutical sciences and concisely explains the history of biomaterials including key developments. Written by experts in the field, this volume within the Advances in Pharmaceutical Product Development and Research series deepens understanding of biomaterials and bionanotechnology within drug discovery and drug development. Each chapter delves into a particular aspect of this fast-moving field to cover the fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to transform a drug candidate or new chemical entity into a final administrable dosage form, with particular focus on biomaterials and bionanomaterials. This book provides a comprehensive examination suitable for researchers working in the pharmaceutical, cosmetics, biotechnology, food and related industries as well as advanced students in these fields.

  • New Developments in Nanosensors for Pharmaceutical Analysis

    • 1 Edición
    • Sibel A. Ozkan + 1 más
    • Inglés
    New Developments for Nanosensors in Pharmaceutical Analysis presents an overview of developments in nanosensor usage in pharmaceutical analysis, thereby helping pharmaceutical companies attain reliable, precise, and accurate analysis of pharmaceuticals. This book presents very simple, precise, sensitive, selective, fast, and relatively inexpensive methods for pre-treatment, prior to analysis. These methods may be considered for further application in clinical studies and assays. The book includes the manufacturing of sensors for pharmaceutical analysis at nano- or smaller scales, and gives simple and relatable designs for the fabrication of sensors. Twelve chapters cover an introduction to the topic, immobilization techniques, mechanism effect of nanomaterials on structure, optical nanosensors for pharmaceutical detection, chemical nanosensors in pharmaceutical analysis, noble metal nanoparticles in electrochemical analysis of drugs, photo-electrochemica... nanosensors for drug analysis, molecularly imprinted polymer based nanosensors for pharmaceutical analysis, nanomaterials for drug delivery systems, nanomaterials enriched nucleic acid-based biosensors, nanosensors in biomarker detection, and nanomaterials-based enzyme biosensors for electrochemical applications.

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