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Elsevier

Books in Pharmaceutical sciences

Elsevier's Pharmaceutical Sciences collection helps pharmaceutical scientists striving to optimize drug design and improve healthcare outcomes by offering comprehensive coverage of every aspect of drug development, integrating disciplines like organic chemistry, biology, and biotechnology. Focused on safety, efficacy, and formulation design, it includes specialized fields such as Clinical Pharmacology and Translational Research, providing valuable insights into the latest advancements in drug discovery.

  • Multivariate Analysis in the Pharmaceutical Industry

    • 1st Edition
    • Ana Patricia Ferreira + 2 more
    • English
    Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each step. It includes an overview of regulatory guidance specific to the use of these methods, along with perspectives on the applications of these methods that allow for testing, monitoring and controlling products and processes. The book seeks to put multivariate analysis into a pharmaceutical context for the benefit of pharmaceutical practitioners, potential practitioners, managers and regulators. Users will find a resources that addresses an unmet need on how pharmaceutical industry professionals can extract value from data that is routinely collected on products and processes, especially as these techniques become more widely used, and ultimately, expected by regulators.

  • Nanotechnology-Based Targeted Drug Delivery Systems for Brain Tumors

    • 1st Edition
    • Prashant Kesharwani + 1 more
    • English
    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.

  • Pharmacy Education in the Twenty First Century and Beyond

    Global Achievements and Challenges
    • 1st Edition
    • Ahmed Fathelrahman + 3 more
    • English
    Pharmacy Education in the Twenty First Century and Beyond: Global Achievements and Challenges offers a complete reference on global pharmacy education, along with a detailed discussion of future issues and solutions. This book begins with a brief overview of the history of pharmacy education, covering all levels of education and styles of learning, from undergraduate, continuing professional education, and methods for self-learning and development. Teaching strategies such as team-based learning, problem-based learning and interdisciplinary education are also described and compared to conclude why certain pharmacy programs attract students, and why educators prefer particular teaching strategies, assessment tools and learning styles. As a result, this book provides pharmacy educators, administrators, students and practitioners with a comprehensive guide to pharmacy education that will enable readers to choose the best approaches to improve, reform or select a program based on worldwide experience and the latest available evidence and research.

  • FDA's Drug Review Process and the Package Label

    Strategies for Writing Successful FDA Submissions
    • 1st Edition
    • Tom Brody
    • English
    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
    • 1st Edition
    • Anthony J. Hickey
    • English
    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

    • 1st Edition
    • Divya Vohora + 1 more
    • English
    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
    • 1st Edition
    • Mohamed Izham Mohamed Ibrahim + 2 more
    • English
    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
    • 1st Edition
    • Volume 39
    • English
    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

    • 1st Edition
    • Padma Nambisan
    • English
    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
    • 1st Edition
    • Phillip S. Levin + 1 more
    • English
    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.

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