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Elsevier

Libros en Ciencias Farmacéuticas

  • An Overview of FDA Regulated Products

    From Drugs and Cosmetics to Food and Tobacco
    • 1 Edición
    • Eunjoo Pacifici + 1 más
    • Inglés
    Approx.270 pages

  • 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.

  • Multivariate Analysis in the Pharmaceutical Industry

    • 1 Edición
    • Ana Patricia Ferreira + 2 más
    • Inglés
    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

    • 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.

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