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Elsevier

Libros en Ciencias Farmacéuticas

  • Advanced Issue Resolution in Safety Pharmacology

    • 1 Edición
    • Mary Jeanne Kallman + 1 más
    • Inglés
    Advanced Issue Resolution in Safety Pharmacology not only discusses unique issues that may emerge during the development of new medicines, but also provides detailed insights on how to resolve them. The book employs a valuable strategy that integrates preclinical findings with the clinical resolution of those findings. In addition, it introduces key interdisciplinary topics in an accessible and systematic format. Edited and written by leaders in the field of safety pharmacology, this book considerably advances the discussion on issue resolution topics, thus raising them to the next level of importance by providing scientists with an indispensable resource on solving safety issues.

  • Handbook of Pharmaceutical Wet Granulation

    Theory and Practice in a Quality by Design Paradigm
    • 1 Edición
    • Ajit S. Narang + 1 más
    • Inglés
    Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm 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. The books' focus on process analytical technology, quality by design principles, granulation equipment, modeling, scale-up, control and real time release makes it a timely and valuable resource for all those involved in pharmaceutical wet granulation.

  • Dosage Form Design Considerations

    Volume I
    • 1 Edición
    • Inglés
    Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries.

  • Dosage Form Design Parameters

    Volume II
    • 1 Edición
    • Inglés
    Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries.

  • Accelerated Predictive Stability (APS)

    Fundamentals and Pharmaceutical Industry Practices
    • 1 Edición
    • Fenghe Qiu + 1 más
    • Inglés
    Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study chapters from many innovative pharmaceutical companies provide a thorough overview of the current status of APS applications in the pharmaceutical industry. In addition, up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the potential of APS in support of registration stability testing for certain regulatory submissions. This book provides high level strategies for the successful implementation of APS in a pharmaceutical company. It offers scientists and regulators a comprehensive resource on how the pharmaceutical industry can enhance their understanding of a product’s stability and predict drug expiry more accurately and quickly.

  • Diagnostic and Therapeutic Applications of Exosomes in Cancer

    • 1 Edición
    • Mansoor M. Amiji + 1 más
    • Inglés
    Diagnostic and Therapeutic Applications of Exosomes in Cancer evaluates the potential of exosome content manipulation in the development of novel therapeutics. In recent years, exosomes, the small vesicles produced by all cell types, have been identified as contributors to cancer growth and metastasis. However, due to their unique biophysical properties, they are also being tested for use in therapeutic design and delivery, as well as in diagnostics. This book presents a comprehensive analysis on exosomes, with a main emphasis on their biogenesis and signaling, use as biomarkers, and as tools for imaging, drug delivery and the treatment of cancer.

  • Nanotechnology-Based Targeted Drug Delivery Systems for Brain Tumors

    • 1 Edición
    • Prashant Kesharwani + 1 más
    • Inglés
    Nanotechnology-Based Targeted Drug Delivery Systems for Brain Tumors addresses brain anatomy and tumors and the progress and challenges in delivering drugs across the blood brain barrier. Several chapters are devoted to the latest technologies and advances in nanotechnology, along with practical solutions on how to design more effective nanocarriers for drug and gene delivery. This valuable resource prepares readers to develop novel drug delivery systems for the treatment of brain tumors that further promote the latest nanomedical technologies.

  • FDA's Drug Review Process and the Package Label

    Strategies for Writing Successful FDA Submissions
    • 1 Edición
    • Tom Brody
    • Inglés
    FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label.

  • Inhaled Pharmaceutical Product Development Perspectives

    Challenges and Opportunities
    • 1 Edición
    • Anthony J. Hickey
    • Inglés
    Inhaled Pharmaceutical Product Development Perspectives: Challenges and Opportunities describes methods and procedures for consideration when developing inhaled pharmaceuticals, while commenting on product development strategies and their suitability to support regulatory submission. It bridges the gap between the aspirations of scientists invested in new technology development and the requirements that must be met for any new product. The book brings together emerging analytical and inhalation technologies, providing perspectives that illuminate formulation and device design, development, regulatory compliance, and practice. Focusing on underlying scientific and technical principles known to be acceptable from the current regulatory perspective, this monograph will remain useful as a high-level guide to inhaled product development for the foreseeable future.

  • Pharmaceutical Medicine and Translational Clinical Research

    • 1 Edición
    • Divya Vohora + 1 más
    • Inglés
    Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features.As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource.

  • Social and Administrative Aspects of Pharmacy in Low- and Middle-Income Countries

    Present Challenges and Future Solutions
    • 1 Edición
    • Mohamed Izham Mohamed Ibrahim + 2 más
    • Inglés
    Social and Administrative Aspects of Pharmacy in Low- and Middle-Income Countries: Present Challenges and Future Solutions examines the particularities of low- and middle-income countries and offers solutions based on their needs, culture and available resources. Drawing from the firsthand experience of researchers and practitioners working in these countries, this book addresses the socio-behavioral aspects of pharmacy and health, pharmacoeconomics, pharmaceutical policy, supply management and marketing, pharmacoepidemiology and public health pharmacy specific to low- and middle-income countries. While some practices may be applied appropriately in disparate places, too often pharmacy practice in low- and middle-income countries is directly copied from successes in developed countries, despite the unique needs and challenges low- and middle-income countries face.

  • Side Effects of Drugs Annual

    A Worldwide Yearly Survey of New Data in Adverse Drug Reactions
    • 1 Edición
    • Volumen 39
    • Inglés
    Side Effects of Drugs Annual: A Worldwide Yearly Survey of New Data in Adverse Drug Reactions, Volume 39 presents the latest on a variety of topics, with new chapters in this volume covering Central nervous system stimulants and drugs that suppress appetite, Antidepressant drugs, Lithium, Drugs of abuse, Hypnotics and sedatives, Antipsychotic Drugs, Antiepileptic Drugs, Opioid analgesics and narcotic antagonists, Anti-inflammatory and antipyretic analgesics and drugs used in gout, General anesthetics and therapeutic gases, Local anesthetics, Neuromuscular blocking agents and skeletal muscle relaxants, and more. First published in 1977, and continually published as a yearly update, this series provides clinicians and medical investigators with a reliable and critical survey of new data and trends in the area of adverse drug reactions and interactions, with an international team of specialists contributing their expertise each year.

  • An Introduction to Ethical, Safety and Intellectual Property Rights Issues in Biotechnology

    • 1 Edición
    • Padma Nambisan
    • Inglés
    An Introduction to Ethical, Safety and Intellectual Property Rights Issues in Biotechnology provides a comprehensive look at the biggest technologies that have revolutionized biology since the early 20th century, also discussing their impact on society. The book focuses on issues related to bioethics, biosafety and intellectual property rights, and is written in an easy-to-understand manner for graduate students and early career researchers interested in the opportunities and challenges associated with advances in biotechnology. Important topics covered include the Human Genome Project, human cloning, rDNA technology, the 3Rs and animal welfare, bioterrorism, human rights and genetic discrimination, good laboratory practices, good manufacturing practices, the protection of biological material and much more. Full of relevant case studies, practical examples, weblinks and resources for further reading, this book offers an essential and holistic look at the ways in which biotechnology has affected our global society.

  • Conservation for the Anthropocene Ocean

    Interdisciplinary Science in Support of Nature and People
    • 1 Edición
    • Phillip S. Levin + 1 más
    • Inglés
    Conservation for the Anthropocene Ocean: Interdisciplinary Science in Support of Nature and People emphasizes strategies to better connect the practice of marine conservation with the needs and priorities of a growing global human population. It conceptualizes nature and people as part of shared ecosystems, with interdisciplinary methodologies and science-based applications for coupled sustainability. A central challenge facing conservation is the development of practical means for addressing the interconnectedness of ecosystem health and human well-being, advancing the fundamental interdisciplinary science that underlies conservation practice, and implementing this science in decisions to manage, preserve, and restore ocean ecosystems. Though humans have intentionally and unintentionally reshaped their environments for thousands of years, the scale and scope of human influence upon the oceans in the Anthropocene is unprecedented. Ocean science has increased our knowledge of the threats and impacts to ecological integrity, yet the unique scale and scope of changes increases uncertainty about responses of dynamic socio-ecological systems. Thus, to understand and protect the biodiversity of the ocean and ameliorate the negative impacts of ocean change on people, it is critical to understand human beliefs, values, behaviors, and impacts. Conversely, on a human-dominated planet, it is impossible to understand and address human well-being and chart a course for sustainable use of the oceans without understanding the implications of environmental change for human societies that depend on marine ecosystems and resources. This work therefore presents a timely, needed, and interdisciplinary approach to the conservation of our oceans.

  • Nanotechnology-Based Approaches for Targeting and Delivery of Drugs and Genes

    • 1 Edición
    • Vijay Mishra + 3 más
    • Inglés
    Nanotechnology-Based Approaches for Targeting and Delivery of Drugs and Genes provides an overview of the important aspects of nanomedicine in order to illustrate how to design and develop novel and effective drug delivery systems using nanotechnology. The book is organized into three sections, beginning with an introduction to nanomedicine and its associated issues. Section two discusses the latest technologies in nanomedicine, while the third section covers future developments and challenges in the field. By focusing on the design, synthesis, and application of a variety of nanocarriers in drug and gene delivery, this book provides pharmaceutical and materials science students, professors, clinical researchers, and industry scientists with a valuable resource aimed at tackling the challenges of delivering drugs and genes in a more targeted manner.

  • Profiles of Drug Substances, Excipients, and Related Methodology

    • 1 Edición
    • Volumen 42
    • Inglés
    Profiles of Drug Substances, Excipients, and Related Methodology, Volume 42 presents comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients, thus meeting the needs of the pharmaceutical community and allowing for the development of a timely vehicle for publishing review materials on the topic. This latest release covers a variety of substances, including Cinacalcet Hydrochloride, Clenbuterol Hydrochloride, Gliclazide, Lomefloxacin, Olmesartan, Propranolol, and Tolterodine Tartrate. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories, Physical profiles of drug substances and excipients, Analytical profiles of drug substances and excipients, Drug metabolism and pharmacokinetic profiles of drug substances and excipients, Methodology related to the characterization of drug substances and excipients, Methods of chemical synthesis, and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients.

  • Nanostructures for Oral Medicine

    • 1 Edición
    • Ecaterina Andronescu + 1 más
    • Inglés
    Nanostructures for Oral Medicine presents an up-to-date examination of the applications and effects of nanostructured materials in oral medicine, with each chapter addressing recent developments, specific applications, and uses of nanostructures in the oral administration of therapeutic agents in dentistry. The book also includes coverage of the biocompatibility of nanobiomaterials and their remarkable potential in improving human health and in reducing environmental pollution. Emerging advances, such as Dr. Franklin Tay's concept of a new nanotechnology process of growing extremely small, mineral-rich crystals and guiding them into the demineralized gaps between collagen fibers to prevent the aging and degradation of resin-dentin bonding is also discussed. This work will be of great value to those who work in oral medicine, providing them with a resource to gain a greater understanding of how nanotechnology can help them create more efficient, cost-effective products. In addition, it will be of great interest to those who work in materials science who wish to gain a greater appreciation of how nanostructured materials are applied in this field.

  • How to Optimize Fluid Bed Processing Technology

    Part of the Expertise in Pharmaceutical Process Technology Series
    • 1 Edición
    • Dilip Parikh
    • Inglés
    How to Optimize Fluid Bed Processing Technology: Part of the Expertise in Pharmaceutical Process Technology Series addresses the important components of fluid bed granulation, providing answers to problems that commonly arise and using numerous practical examples and case studies as reference. This book covers the theoretical concepts involved in fluidization, also providing a description of the choice and functionality of equipment. Additional chapters feature key aspects of the technology, including formulation requirements, process variables, process scale-up, troubleshooting, new development, safety, and process evaluation. Given its discussion of theoretical principles and practical solutions, this is a go-to resource for all those scientists and new researchers working with fluid bed granulation as a unit operation.

  • Nano- and Microscale Drug Delivery Systems

    Design and Fabrication
    • 1 Edición
    • Alexandru Mihai Grumezescu
    • Inglés
    Nano- and Microscale Drug Delivery Systems: Design and Fabrication presents the developments that have taken place in recent years in the field of micro- and nanoscale drug delivery systems. Particular attention is assigned to the fabrication and design of drug delivery systems in order to i) reduce the side effects of therapeutic agents, ii) increase their pharmacological effect, and iii) improve aqueous solubility and chemical stability of different therapeutic agents. This book is designed to offer a cogent, concise overview of current scholarship in this important area of research through its focus on the characterization and fabrication of a variety of nanomaterials for drug delivery applications. It is an invaluable reference source for both biomaterials scientists and biomedical engineers who want to learn more about how nanomaterials are engineered and used in the design of drug delivery nanosystems.

  • Nanostructures for Drug Delivery

    • 1 Edición
    • Ecaterina Andronescu + 1 más
    • Inglés
    Nanostructures for Drug Delivery extensively covers the various nanostructured products that have been tested as carriers in target drug delivery systems. In addition, the book analyses the advantages of, and issues related to, using nanostructured materials in drug delivery systems, also detailing various nanocarrier preparation techniques. As delivering the drug to the target site is a major problem in providing effective treatment for many diseases, this book covers the latest advancements in numerous nanotechnological products that are being used in disease detection, controlled drug delivery, as biosensors, and in tissue engineering that have been developed for more efficient patient healthcare. Due to the versatility of nanostructured materials, it is now possible to deliver a drug at its target site in a more accurate and efficient way. This volume is an up-to-date, state-of-the-art work that highlights the principal mechanistic aspects related to the delivery of active nanoscale therapeutic agents (natural or synthetic) and their release profile in different environmental media. It highlights nanoscale encapsulation strategies and discusses both organic and inorganic nanomaterials as carriers and delivery platforms.

  • Vascular Pharmacology

    Smooth Muscle
    • 1 Edición
    • Volumen 78
    • Inglés
    Vascular Pharmacology: Smooth Muscle provides up-to-date information on the structure, function, signaling, and development of vascular smooth muscle. Contributors include prominent scientists and highly-recognized experts with major accomplishments in the field of vascular smooth muscle research.

  • Emerging Nanotechnologies for Diagnostics, Drug Delivery and Medical Devices

    • 1 Edición
    • Ashim K Mitra + 2 más
    • Inglés
    Emerging Nanotechnologies for Diagnostics, Drug Delivery and Medical Devices covers the modern micro and nanotechnologies used for diagnosis, drug delivery, and theranostics using micro, nano, and implantable systems. In-depth coverage of all aspects of disease treatment is included. In addition, the book covers cutting-edge research and technology that will help readers gain knowledge of novel approaches and their applications to improve drug/agent specificity for diagnosis and efficient disease treatment. It is a comprehensive guide for medical specialists, the pharmaceutical-indus... and academic researchers discussing the impact of nanotechnology on diagnosis, drug delivery, and theranostics.

  • Translational Immunotherapy of Brain Tumors

    • 1 Edición
    • John H. Sampson
    • Inglés
    Translational Immunotherapy of Brain Tumors gives researchers and practitioners an up-to-date and comprehensive overview of the field. Chapters include adoptive immunotherapy, immunosuppression, CAR therapy of brain tumors, and dendritic cell therapy for brain tumors. Very few agents have been shown to be efficacious in the treatment of malignant gliomas. Recently, there have been a number of studies demonstrating the potential success of immunotherapy for brain tumors. Immunotherapeutics are becoming the most frequent drugs to be used in cancer therapy. These new breakthroughs, now approved by the FDA, are a part of multiple phase III international trials and ongoing research in malignant glioma, meaning that the information in this cutting-edge book will be of great importance to practitioners and researchers alike. 2018 BMA Medical Book Awards Highly Commended in Oncology

  • Microsized and Nanosized Carriers for Nonsteroidal Anti-Inflammatory Drugs

    Formulation Challenges and Potential Benefits
    • 1 Edición
    • Bojan Čalija
    • Inglés
    Microsized and Nanosized Carriers for Nonsteroidal Anti-Inflammatory Drugs: Formulation Challenges and Potential Benefits provides a unique and complete overview of novel formulation strategies for improvement of the delivery of NSAIDs via encapsulation in microsized and nanosized carriers composed of different materials of natural and synthetic origin. This book presents the latest research on advances and limitations of both microsized and nanosized drug carriers and NSAIDs before discussing the formulation aspects of these drug carriers that are intended for oral, dermal, and transdermal administration of NSAIDs. In addition, functionality of these materials as potential excipients for microsized and nanosized carriers is discussed and debated. Practical solutions for improving effectiveness of these drugs are included throughout the book, making this an important resource for graduate students, professors, and researchers in the pharmaceutical sciences.

  • Modeling of Microscale Transport in Biological Processes

    • 1 Edición
    • Sid M. Becker
    • Inglés
    Modeling of Microscale Transport in Biological Processes provides a compendium of recent advances in theoretical and computational modeling of biotransport phenomena at the microscale. The simulation strategies presented range from molecular to continuum models and consider both numerical and exact solution method approaches to coupled systems of equations. The biological processes covered in this book include digestion, molecular transport, microbial swimming, cilia mediated flow, microscale heat transfer, micro-vascular flow, vesicle dynamics, transport through bio-films and bio-membranes, and microscale growth dynamics. The book is written for an advanced academic research audience in the fields of engineering (encompassing biomedical, chemical, biological, mechanical, and electrical), biology and mathematics. Although written for, and by, expert researchers, each chapter provides a strong introductory section to ensure accessibility to readers at all levels.

  • Pharmacy Management Software for Pharmacy Technicians: A Worktext

    • 3 Edición
    • DAA Enterprises, Inc.
    • Inglés
    Acquire the skills to succeed in the pharmacy, before leaving the classroom, with Pharmacy Management Software for Pharmacy Technicians, 3rd Edition. This innovative software/worktext incorporates the full version of DAA Enterprises' Visual Superscript pharmacy management software to give you hands-on training performing the day-to-day tasks of a pharmacy technician — just as you will on the job. Expanded lab content, an updated drug database, and correlation with ASHP standards provide you with a comprehensive, current product to get you practice ready Easy-to-follow, step-by-step instructions guide you through essential functions in community and institutional pharmacy practice.

  • Managing the Drug Discovery Process

    How to Make It More Efficient and Cost-Effective
    • 1 Edición
    • Susan Miller + 3 más
    • Inglés
    Managing the Drug Discovery Process: How to Make It More Efficient and Cost-Effective thoroughly examines the current state of pharmaceutical research and development by providing chemistry-based perspectives on biomedical research, drug hunting and innovation. The book also considers the interplay of stakeholders, consumers, and the drug firm with attendant factors, including those that are technical, legal, economic, demographic, political, social, ecological, and infrastructural. Since drug research can be a high-risk, high-payoff industry, it is important to researchers to effectively and strategically manage the drug discovery process. This book takes a closer look at increasing pre-approval costs for new drugs and examines not only why these increases occur, but also how they can be overcome to ensure a robust pharmacoeconomic future. Written in an engaging manner and including memorable insights, this book is aimed at redirecting the drug discovery process to make it more efficient and cost-effective in order to achieve the goal of saving countless more lives through science. A valuable and compelling resource, this is a must-read for all students and researchers in academia and the pharmaceutical industry.

  • Developing Solid Oral Dosage Forms

    Pharmaceutical Theory and Practice
    • 2 Edición
    • Yihong Qiu + 4 más
    • Inglés
    Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process. New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more.

  • Economic Evaluation of Pharmacy Services

    • 1 Edición
    • Zaheer-Ud-Din Babar
    • Inglés
    Economic Evaluation of Pharmacy Services provides the latest on the trend to a more product-centered and service-centered practice, eschewing traditional economic evaluation techniques that focus on product-to-product comparisons in favor of evaluating processes that measure costs and health outcomes. Complete with examples focusing on best practices, including various study designs, types of pharmacy services, and types of outcomes being evaluated, the book emphasizes case studies and examples that help readers understand economic evaluation techniques. Many of these techniques are transferable across countries, especially where there are advanced and stable health systems in place. With the help of this practical guide, readers will gain a thorough understanding of the application of economic evaluation of pharmacy services.

  • How to Develop Robust Solid Oral Dosage Forms

    From Conception to Post-Approval
    • 1 Edición
    • Bhavishya Mittal
    • Inglés
    How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips. By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms.

  • Preserving the Promise

    Improving the Culture of Biotech Investment
    • 1 Edición
    • Scott Dessain + 1 más
    • Inglés
    Preserving the Promise: Improving the Culture of Biotech Investment critically examines why most biotech startups fail, as they emerge from universities into an ecosystem that inhibits rather than encourages innovation. This "Valley of Death" squanders our public investments in medical research and with them, the promise of longer and healthier lives. The authors explicate the Translation Gap faced by early stage biotech companies, the result of problematic technology transfer and investment practices, and provide specific prescriptions for improving translation of important discoveries into safe and effective therapies. In Preserving the Promise, Dessain and Fishman build on their collective experience as company founders, healthcare investor (Fishman) and physician/scientist (Dessain). The book offers a forward-looking, critical analysis of "conventional wisdom" that encumbers commercialization practices. It exposes the self-defeating habits of drug development in the Valley of Death, that waste money and extinguish innovative technologies through distorted financial incentives.

  • 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.

  • Drug Metabolism in Diseases

    • 1 Edición
    • Wen Xie
    • Inglés
    Drug Metabolism in Diseases is a comprehensive reference devoted to the current state of research on the impact of various disease states on drug metabolism. The book contains valuable insights into mechanistic effects and examples of how to accurately predict drug metabolism during these different pathophysiological states. Each chapter clearly presents the effects of changes in drug metabolism and drug transporters on pharmacokinetics and disposition. This is a unique and useful approach for all those involved in drug discovery and development, and for clinicians and researchers in drug metabolism, pharmacology, and clinical pharmacology.

  • Dynemicin A, Uncialamycin and Analogues

    • 1 Edición
    • Daniel Best + 2 más
    • Inglés
    Enediynes are natural products with highly active cytotoxicity and antibacterial activity, and thus have significant potential in the development of anti-cancer treatments. However, they are not readily available and can degrade rapidly during isolation; one solution is to produce them using total synthesis.Dynemicin A and uncialamycin are two such enediynes, with similar structures, for which total synthesis has been achieved. This book presents the isolation and preparation of these two compounds and their analogues through various synthesis strategies. Details of the structural elements essential to their anti-cancer activity are presented, with the objective of explaining and optimizing their biological activities and potential development as drugs.

  • How to Validate a Pharmaceutical Process

    • 1 Edición
    • Steven Ostrove
    • Inglés
    How to Validate a Pharmaceutical Process provides a “how to” approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the “why” is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation.

  • Profiles of Drug Substances, Excipients and Related Methodology

    • 1 Edición
    • Volumen 41
    • Inglés
    Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients.

  • Pharmacy Practice in Developing Countries

    Achievements and Challenges
    • 1 Edición
    • Ahmed Fathelrahman + 2 más
    • Inglés
    Pharmacy Practice in Developing Countries: Achievements and Challenges offers a detailed review of the history and development of pharmacy practice in developing countries across Africa, Asia, and South America. Pharmacy practice varies substantially from country to country due to variations in needs and expectations, culture, challenges, policy, regulations, available resources, and other factors. This book focuses on each country’s strengths and achievements, as well as areas of weakness, barriers to improvement and challenges. It sets out to establish a baseline for best practices, taking all of these factors into account and offering solutions and opportunities for the future. This book is a valuable resource for academics, researchers, practicing pharmacists, policy makers, and students involved in pharmacy practice worldwide as it provides lessons learned on a global scale and seeks to advance the pharmacy profession.

  • Social Aspects of Drug Discovery, Development and Commercialization

    • 1 Edición
    • Odilia Osakwe + 1 más
    • Inglés
    Social Aspects of Drug Discovery, Development and Commercialization provides an insightful analysis of the drug discovery and development landscape as it relates to society. This book examines the scientific, legal, philosophical, economic, political, ethical and cultural factors that contribute to drug development. The pharmaceutical industry is under scrutiny to develop safer and more effective drugs in a quicker and more affordable manner. Recent criticism and debates have emphasized varying opinions on the issues concerning the drug discovery and development process. This book provides thoughtful and valuable discussions and analysis of the social challenges and potential opportunities through all stages of the pharmaceutical process, from inception through marketing. With a unique focus on the social factors that increasingly play a role in how drug development is planned, structured, and executed throughout the drug product lifecycle, this is an essential resource for students, professors, and researchers who seek a better understanding of the interface between the pharmaceutical industry, health care systems, and society.

  • CAPA in the Pharmaceutical and Biotech Industries

    How to Implement an Effective Nine Step Program
    • 1 Edición
    • J Rodriguez
    • Inglés
    CAPA in the Pharmaceutical and Biotech Industries: How to Implement an Effective Nine Step Program contains the most current information on how to implement, develop, and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a nine step closed-loop process approach for medical devices and pharmaceutical and biologic manufacturers, as well as any anyone who has to maintain a quality system.This book addresses how companies often make the mistake of fixing problems in their processes by revising procedures or, more commonly, by retraining employees that may or may not have caused the problem. This event-focused fix leads to the false assumption that the errors have been eradicated and will be prevented in the future. The reality is that the causes of the failure were never actually determined, therefore the same problem will recur over and over. CAPA is a complete system that collects information regarding existing and potential quality problems. It analyzes and investigates the issues to identify the root cause of nonconformities. It is not just a quick-fix, simple approach, it is a process and has to be understood throughout organizations.

  • Essential Chemistry for Formulators of Semisolid and Liquid Dosages

    • 1 Edición
    • Vitthal S. Kulkarni + 1 más
    • Inglés
    A needed resource for pharmaceutical scientists and cosmetic chemists, Essential Chemistry for Formulators of Semisolid and Liquid Dosages provides insight into the basic chemistry of mixing different phases and test methods for the stability study of nonsolid formulations. The book covers foundational surface/colloid chemistry, which forms the necessary background for making emulsions, suspensions, solutions, and nano drug delivery systems, and the chemistry of mixing, which is critical for further formulation of drug delivery systems into semisolid (gels, creams, lotions, and ointments) or liquid final dosages. Expanding on these foundational principles, this useful guide explores stability testing methods, such as particle size, rheological/viscosit... microscopy, and chemical, and closes with a valuable discussion of regulatory issues. Essential Chemistry for Formulators of Semisolid and Liquid Dosages offers scientists and students the foundation and practical guidance to make and analyze semisolid and liquid formulations.

  • Artificial Neural Network for Drug Design, Delivery and Disposition

    • 1 Edición
    • Munish Puri + 4 más
    • Inglés
    Artificial Neural Network for Drug Design, Delivery and Disposition provides an in-depth look at the use of artificial neural networks (ANN) in pharmaceutical research. With its ability to learn and self-correct in a highly complex environment, this predictive tool has tremendous potential to help researchers more effectively design, develop, and deliver successful drugs. This book illustrates how to use ANN methodologies and models with the intent to treat diseases like breast cancer, cardiac disease, and more. It contains the latest cutting-edge research, an analysis of the benefits of ANN, and relevant industry examples. As such, this book is an essential resource for academic and industry researchers across the pharmaceutical and biomedical sciences.

  • Pharmaceutical Microbiology

    Essentials for Quality Assurance and Quality Control
    • 1 Edición
    • Tim Sandle
    • Inglés
    Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality. The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control.

  • A Practical Guide to Rational Drug Design

    • 1 Edición
    • Sun Hongmao
    • Inglés
    This book is not going to be an exhaustive survey covering all aspects of rational drug design. Instead, it is going to provide critical know-how through real-world examples. Relevant case studies will be presented and analyzed to illustrate the following: how to optimize a lead compound whether one has high or low levels of structural information; how to derive hits from competitors’ active compounds or from natural ligands of the targets; how to springboard from competitors’ SAR knowledge in lead optimization; how to design a ligand to interfere with protein-protein interactions by correctly examining the PPI interface; how to circumvent IP blockage using data mining; how to construct and fully utilize a knowledge-based molecular descriptor system; how to build a reliable QSAR model by focusing on data quality and proper selection of molecular descriptors and statistical approaches. A Practical Guide to Rational Drug Design focuses on computational drug design, with only basic coverage of biology and chemistry issues, such as assay design, target validation and synthetic routes.

  • Laboratory Animal Anaesthesia

    • 4 Edición
    • Paul Flecknell
    • Inglés
    Laboratory Animal Anaesthesia, Fourth Edition provides a basic guide to anaesthesia for a very diverse audience needing content, with straight-forward, structured style of writing. Updated with effects of anaesthetics in different laboratory species, including sources of dose rates will be incorporated into tabular material. New information on pain assessment and pain management will be covered, and an increased emphasis on rats and mice for anaesthesia and perioperative care. With newly revised, full color illustrations to facilitate best learning, Laboratory animal Anesthesia, Fourth Edition provides procedures, key points and invaluable advice from a well-known and respected veterinary anesthetist and scientist with over 30 years of experience in the field.

  • Inorganic Controlled Release Technology

    Materials and Concepts for Advanced Drug Formulation
    • 1 Edición
    • Xiang Zhang + 1 más
    • Inglés
    Inorganic Controlled Release Technology: Materials and Concepts for Advanced Drug Formulation provides a practical guide to the use and applications of inorganic controlled release technology (iCRT) for drug delivery and other healthcare applications, focusing on newly developed inorganic materials such as bioresorbable glasses and bioceramics. The use of these materials is introduced for a wide range of applications that cover inorganic drug delivery systems for new drug development and the reformulation of existing drugs. The book describes basic concepts, principles, and industrial practices by discussing materials chemistry, physics, nano/microstructure, formulation, materials processing, and case studies, as well as the evaluation and characterization of iCRT systems commonly investigated during industrial R&D.

  • Nonclinical Assessment of Abuse Potential for New Pharmaceuticals

    • 1 Edición
    • Carrie Markgraf + 2 más
    • Inglés
    Nonclinical Assessment of Abuse Potential for New Pharmaceuticals offers a complete reference on the current international regulatory guidelines and details best practice methodology for the three standard animal models used to evaluate abuse potential: physical dependence, self-administration and drug discrimination. This book also includes chapters on alternative models and examples of when you should use these alternatives. Case histories are provided at the end of the book to show how the data generated from the animal models play a pivitol role in the submission package for a new drug. By incorporating all of this information into one book, Nonclinical Assessment of Abuse Potential for New Pharmaceuticals is your single resource for everything you need to know to understand and implement the assessment of abuse liability.

  • Prodrug Design

    Perspectives, Approaches and Applications in Medicinal Chemistry
    • 1 Edición
    • Vivekkumar K Redasani + 1 más
    • Inglés
    Prodrug Design: Perspectives, Approaches and Applications in Medicinal Chemistry provides a focused overview of this critical area of drug discovery, as that continuous process strives not only to discover new drug compounds but also to modify the existing ones. This valuable primer supports this mission of drug development and its goal of reducing undesired effects and improving therapeutic effectiveness of drug compounds. Providing a unique compilation of data, insightful case studies, and review of existing literature in the area, the book will promote innovation in medicinal and pharmaceutical chemistry research, exploring the limitations of existing drugs and their improvement. Prodrug Design reviews marketed compounds, the safety of promoieties, and a detailed classification of prodrugs organized by therapeutic area for easy reference.

  • Strategies to Modify the Drug Release from Pharmaceutical Systems

    • 1 Edición
    • Marcos Luciano Bruschi
    • Inglés
    Since the earliest dosage forms to modern drug delivery systems, came a great development and growth of knowledge with respect to drug delivery. Strategies to Modify the Drug Release from Pharmaceutical Systems will address principles, systems, applications and advances in the field.It will be principally a textbook and a reference source of strategies to modify the drug release. Moreover, the characterization, mathematical and physicochemical models, applications and the systems will be discussed.

  • Drug Design and Discovery in Alzheimer’s Disease

    • 1 Edición
    • Atta-ur Rahman + 1 más
    • Inglés
    Drug Design and Discovery in Alzheimer’s Disease includes expert reviews of recent developments in Alzheimer's disease (AD) and neurodegenerative disease research. Originally published by Bentham as Frontiers in Drug Design and Discovery, Volume 6and now distributed by Elsevier, this compilation of the sixteen articles, written by leading global researchers, focuses on key developments in the understanding of the disease at molecular levels, identification and validation of molecular targets, as well as innovative approaches towards drug discovery, development, and delivery. Beginning with an overview of AD pharmacotherapy and existing blockbuster drugs, the reviews cover the potential of both natural and synthetic small molecules; the role of cholinesterases in the on-set and progression of AD and their inhibition; the role of beta-site APP clearing enzyme-1 (BACE-1) in the production of β-amyloid proteins, one of the key reasons of the progression of AD; and other targets identified for AD drug discovery.

  • The Science and Ethics of Antipsychotic Use in Children

    • 1 Edición
    • Nina Di Pietro + 1 más
    • Inglés
    The Science and Ethics of Antipsychotic Use in Children reviews the latest findings for the safety and efficacy of the rapidly rising incidence of antipsychotic use in children and examines tensions that are created by off-label use, both in clinical psychiatric practice and research.In the past ten years, the number of antipsychotics prescribed to children with psychiatric disorders has skyrocketed. Despite this rapid growth, most medications have been inadequately studied in children for safety or efficacy and many have serious adverse health. Measures are needed to ensure that the health and safety of children are being protected, and debates have emerged over whether or not clinical trials in this population should be conducted.

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