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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.

  • Predictive Modeling of Pharmaceutical Unit Operations

    • 1st Edition
    • Preetanshu Pandey + 1 more
    • English
    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.
  • Emerging Targets and Therapeutics in the Treatment of Psychostimulant Abuse

    • 1st Edition
    • Volume 69
    • Linda P. Dwoskin
    • English
    This new volume of Advances in Pharmacology presents the emerging targets and therapeutics in the treatment of psychostimulant abuse. With a variety of chapters and the best authors in the field, the volume is an essential resource for pharmacologists, immunologists and biochemists alike.
  • Lead Compounds from Medicinal Plants for the Treatment of Neurodegenerative Diseases

    • 1st Edition
    • Christophe Wiart
    • English
    Lead Compounds from Medicinal Plants for the Treatment of Neurodegenerative Diseases is the second volume in the series, Pharmaceutical Leads from Medicinal Plants. This book includes key pharmacological and chemical evidence to support the selection of promising pre-clinical candidates for the treatment of neurodegenerative diseases. This important addition to the natural product and drug discovery literature contains the history, synonyms, medicinal uses, phytopharmacology, pre-clinical potential, and rationale for each plant selected. By providing critical evaluation of pharmacological data, mechanisms of action, and structural requirements for the development of future neuroprotective agents, this comprehensive reference is a beneficial resource for industry and academic scientists whose research focuses on neurodegenerative drug discovery and development.
  • International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations

    A Global Perspective
    • 1st Edition
    • Pierre-Louis Lezotre
    • English
    International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective provides the current status of the complex and broad phenomenon of cooperation, convergence and harmonization in the pharmaceutical sector (Part I), thoroughly evaluates its added value and its critical parameters and influencing factors (Part II) in order to recommend actions and measures to support the next steps for cooperation, convergence and harmonization (Part III). All of these recommendations in the book support the establishment of a better coordinated global pharmaceutical system which represents the best realistic alternative to fulfill the objective to establish a global coalition of regulators and to respond to an increased demand to further cooperation in the pharmaceutical sector. This proposed framework, which leverages all of the ongoing positive cooperation initiatives and uses as foundations all of the numerous harmonization projects developed over the years, presents advantages for all stakeholders and would definitively have significant added value to the promotion and protection of global public health.
  • Orphan Drugs

    Understanding the Rare Disease Market and its Dynamics
    • 1st Edition
    • Elizabeth Hernberg-Ståhl + 1 more
    • English
    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.
  • Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

    Technology, Validation and Current Regulations
    • 1st Edition
    • Tim Sandle
    • English
    Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques.
  • Ocular Transporters and Receptors

    Their Role in Drug Delivery
    • 1st Edition
    • Ashim K Mitra
    • English
    Ocular transporters and receptors contains detailed descriptions of major transporters and receptors expressed in the eye, with special emphasis on their role in drug delivery. The complex anatomy and the existence of multiple barriers in the eye pose a considerable challenge to successful drug delivery to the eye. Hence ocular transporters and receptors are important targets for drug delivery. A significant advancement has been made in the field of ocular transport research and their role in drug delivery. In this book the cutting edge research being carried out in this field is compiled and summarized. The book focuses on key areas, including the anatomy and physiology of the eye, biology of ocular transporters and receptors, techniques in characterization of transporters and receptors, transporters and receptors in the anterior and posterior segment in the eye, the role of ocular transporters and receptors in drug delivery, and transporter-metaboli... interplay in the eye.
  • The Funding of Biopharmaceutical Research and Development

    • 1st Edition
    • David R Williams
    • English
    The funding of biopharmaceutical research and development provides a comprehensive critical review of the funding of research and development (R&D) in the human biopharmaceutical market sector. It addresses both private and public funding sources available in the US and internationally. The biopharmaceutical market is among the most research-intensive market sectors globally. Clinical researchers face a multitude of public and private funding options with respect to bringing their idea or innovation to market. These funding options are continually changing and complex, and are expected to decrease in the near future. A lack of understanding of the scale, scope, and inner workings of the funding aspects of R&D can, at times, act as a barrier for all involved, and can slow down or even eliminate the R&D process. The book lessens these barriers by describing the theoretical underpinnings, present practice, and trends in R&D funding in this market sector, both in the US and internationally. This includes a review and discussion of public-private partnership activity and their inner-workings, noting the complementary relationship between public and private funding. The book also contains an overview of the inner-workings of strategic alliance activity, including the advantages and disadvantages for each party. It goes on to provide an outline of venture capital activity, detailing the methods by which venture capital firms raise capital and are organized, a description of the venture capital-entrepreneur arrangement, and the effects of this arrangement. The book also presents an overview of the IPO process and the various fates of firms going public.
  • Drug Design

    Medicinal Chemistry: A Series of Monographs, Vol. 4
    • 1st Edition
    • E. J. Ariëns
    • English
    Drug Design, Volume IV covers the pharmaceutical phase of drug action, with emphasis on those aspects that are of importance in the design of optimally effective drug products. The book discusses biopharmaceutics as a basis for the design of drug products; the types and pharmacokinetics of peroral prolonged action dosage forms and parenteral prolonged action forms; and the design of topical drug products. The text also describes physical-chemical parameters which affect the bioavailability of topical drug products; the design of sunscreen preparations; as well as the clinical application of litholytic agents, which are preventive and curative drugs for nephrolithiasis. The design of biologically active nucleosides and of insecticidal chlorohydrocarbon derivatives is also encompassed. Chemists, biochemists, pharmacologists, and people involved in drug design will find the book invaluable.