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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.

BooksJournals

    • Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

      • 1st Edition
      • October 31, 2013
      • Tim Sandle
      • English
      • Hardback
        9 7 8 1 9 0 7 5 6 8 3 8 1
      • Paperback
        9 7 8 0 0 8 1 0 1 3 6 0 1
      • eBook
        9 7 8 1 9 0 8 8 1 8 6 3 8
      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.

    • Orphan Drugs

      • 1st Edition
      • October 31, 2013
      • Elizabeth Hernberg-Ståhl + 1 more
      • English
      • Hardback
        9 7 8 1 9 0 7 5 6 8 0 9 1
      • Paperback
        9 7 8 0 0 8 1 0 1 3 5 9 5
      • eBook
        9 7 8 1 9 0 8 8 1 8 3 9 3
      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.

    • Quality Assurance

      • 1st Edition
      • June 30, 2013
      • G Welty
      • English
      • Hardback
        9 7 8 1 9 0 7 5 6 8 3 6 7
      • Paperback
        9 7 8 0 0 8 1 0 1 5 9 3 3
      • eBook
        9 7 8 1 9 0 8 8 1 8 6 2 1
      Quality assurance is necessary to maintain quality and services in the pharmaceutical and life science industries. Quality assurance demonstrates that the logic and practice of problem solving can integrate both program efficacy and regulatory compliance. This title is divided into three parts; the first part discusses the process by which a problem in regulated industry is identified, for example a manufacturing deviation that leads to an adulterated drug product, and reviews the decision-making steps involved in remedying the problem. The second part delves into the staff training requirements of procedures that are thereby revised. The third part expands on this discussion by considering piloting the proposed training module, preparing assessments of trainee proficiency, evaluating the training module, including integrating rigorous evaluative designs with formative program improvement, and documenting the entire effort.

    • The Future of Drug Discovery

      • 1st Edition
      • May 18, 2013
      • Tamas Bartfai + 1 more
      • English
      • Paperback
        9 7 8 0 1 2 4 0 7 1 8 0 3
      • eBook
        9 7 8 0 1 2 4 0 9 5 1 9 9
      The Future of Drug Discovery: Who decides which diseases to treat? provides a timely and detailed look at the efforts of the pharmaceutical industry and how they relate, or should relate, to societal needs. The authors posit that as a result of increasing risk aversion and accelerated savings in research and development, the industry is not developing drugs for increasingly prevalent diseases, such as Alzheimer’s disease, untreatable pain, antibiotics and more. This book carefully exposes the gap between the medicines and therapies we need and the current business path. By analyzing the situation and discussing prospects for the next decade, the The Future of Drug Discovery is a timely book for all those who care about the development needs for drugs for disease.

    • The Path from Biomarker Discovery to Regulatory Qualification

      • 1st Edition
      • July 16, 2013
      • Federico Goodsaid + 1 more
      • English
      • Paperback
        9 7 8 0 1 2 3 9 1 4 9 6 5
      • eBook
        9 7 8 0 1 2 3 9 4 4 0 8 5
      The Path from Biomarker Discovery to Regulatory Qualification is a unique guide that focuses on biomarker qualification, its history and current regulatory settings in both the US and abroad. This multi-contributed book provides a detailed look at the next step to developing biomarkers for clinical use and covers overall concepts, challenges, strategies and solutions based on the experiences of regulatory authorities and scientists. Members of the regulatory, pharmaceutical and biomarker development communities will benefit the most from using this book—it is a complete and practical guide to biomarker qualification, providing valuable insight to an ever-evolving and important area of regulatory science. For complimentary access to chapter 13, 'Classic' Biomarkers of Liver Injury, by John R. Senior, Associate Director for Science, Food and Drug Administration, Silver Spring, Maryland, USA, please visit the following site: http://tinyurl.com/C...

    • Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics

      • 1st Edition
      • June 27, 2013
      • Lisa M. Plitnick + 1 more
      • English
      • Hardback
        9 7 8 0 1 2 3 9 4 8 1 0 6
      • eBook
        9 7 8 0 1 2 3 9 4 8 2 3 6
      Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. An edited book that is authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late stage biologics.

    • International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations

      • 1st Edition
      • December 5, 2013
      • Pierre-Louis Lezotre
      • English
      • Hardback
        9 7 8 0 1 2 8 0 0 0 5 3 3
      • eBook
        9 7 8 0 1 2 8 0 0 5 6 9 9
      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.

    • Pharmacy Law and Practice

      • 5th Edition
      • April 19, 2013
      • Jon Merrills + 1 more
      • English
      • Paperback
        9 7 8 0 1 2 3 9 4 2 8 9 0
      • eBook
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      Pharmacy Law and Practice, Fifth Edition provides a straightforward and useable guide for students, practitioners, academics and others interested in pharmacy law and practice in the United Kingdom. This multi-dimensional book includes discussions of socio-political influences on legal developments to provide greater insight to the reader. It clearly sets out the background to regulatory issues together with simple and practical statements of what a pharmacist has to do to obey the law. As in previous editions, this book discusses topics thematically rather than by statute. It is a unique and reader-friendly guide that boils down the complex or difficult language of the law, describes the reasons behind it, and illustrates the application to pharmacy practice.

    • Pharma's Prescription

      • 1st Edition
      • October 21, 2013
      • Kamal Biswas
      • English
      • Paperback
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      • eBook
        9 7 8 0 1 2 4 0 7 6 8 8 4
      The pharmaceutical industry needs a shot in the arm – and not a moment too soon. The executive suite is mired in a bygone era, a time when extensive, well-funded pharmaceutical R&D produced blockbuster drugs, kept everything in-house and reaped the financial rewards. But that way of working needs to change. Executives now need to know what the technologists in their companies are doing in order to survive the next decade. Written for those new to industry, as well as for experienced professionals or specialists looking to expand their knowledge, this book is a must-read for business executives and information technologists alike. Pharma’s Prescription bridges the knowledge gap between current business practices and the most valuable technologies today. This book is filled with practical, real-life examples from industry and is a straightforward guide for all pharmaceutical and information technology executives who need to improve their businesses.

    • Drug Design

      • 1st Edition
      • October 22, 2013
      • E. J. Ariëns
      • English
      • Paperback
        9 7 8 1 4 8 3 2 0 2 6 3 1
      • eBook
        9 7 8 1 4 8 3 2 1 6 0 6 5
      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.

Related subjects

Drug delivery

Drug design

Drug dispensing

Drug manufacturing and packaging

Drug metabolism disposition

Pharmaceutical analysis

Pharmaceutical biotechnology

Pharmaceutical quality control

Pharmaceutical science general

Pharmaceutical technology

Pharmacoeconomics

Pharmacoepidemiology

Pharmacotherapy

Pharmacy

Pharmacy management