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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.

  • Design and Manufacture of Pharmaceutical Tablets

    • 1st Edition
    • Reynir Eyjolfsson
    • English
    Design and Manufacture of Pharmaceutical Tablets offers real world solutions and outcomes of formulation and processing challenges of pharmaceutical tablets. This book includes numerous practical examples related to actual formulations that have been validated and marketed and covers important data in the areas of stability, dissolution, bioavailibity and processing. It provides important background and theoretical information on design and manufacturing and includes a full section dedicated to design experimental methodology and statistics. In addition, this book offers a a general discussion of excipients used in proper tablet design along with practical examples related to excipients. Drug development scientists in industry and academia, as well as students in the pharmaceutical sciences will greatly benefit from the practical knowledge and case examples provided throughout this book.

  • Marine Carbohydrates: Fundamentals and Applications, Part B

    • 1st Edition
    • Volume 73
    • English
    Marine Carbohydrates: Fundamentals and Applications brings together the diverse range of research in this important area which leads to clinical and industrialized products. The volume, number 73, focuses on marine carbohydrates in isolation, biological, and biomedical applications and provides the latest trends and developments on marine carbohydrates. Advances in Food and Nutrition Research recognizes the integral relationship between the food and nutritional sciences and brings together outstanding and comprehensive reviews that highlight this relationship. Volumes provide those in academia and industry with the latest information on emerging research in these constantly evolving sciences.

  • Pharmacology of the Blood Brain Barrier: Targeting CNS Disorders

    • 1st Edition
    • Volume 71
    • English
    This new volume of Advances in Pharmacology presents pharmacology of the blood brain barrier, focusing on targeting CNS disorders. With a variety of chapters and the best authors in the field, the volume is an essential resource for pharmacologists, immunologists and biochemists alike.

  • Handbook of Cosmeceutical Excipients and their Safeties

    • 1st Edition
    • K Y Heng + 5 more
    • English
    Cosmeceuticals are the latest additions to the health industry and have an ever-expanding market. They are considered to be a marriage between cosmetics and drugs and are defined as preparations applied on the body that may modify the physiological functions of the skin. However, as more cosmeceuticals are being launched in the market and more types of drugs are incorporated into the formulation, the composition of cosmeceuticals is becoming more complex. Handbook of Cosmeceutical Excipients and their Safeties summarises the current evidence relating to cosmeceuticals’ side effects and highlights the important information that practitioners and consumers need to know, as well as ways to avoid the adverse effects of the excipients. Handbook of Cosmeceutical Excipients and their Safeties includes chapters covering topics such as the history of cosmeceuticals and the laws that regulate them, skin permeation, carcinogenicity as a systemic adverse effect and dermatitis as a topical adverse effect. It concludes with an appendix that gives brief information on the potency and permeability of common ingredients in cosmeceuticals. The appendix aims to highlight the maximum allowable quantity of each ingredient to ensure product safety for consumers. The appendix was prepared by compiling the ingredients of 257 products containing more than 500 compounds, collected from a hospital pharmacy in Singapore.

  • PROP - Pharmaceutical Calculations Custom Text

    • 1st Edition
    • Anthem
    • English

  • Colloid and Interface Science in Pharmaceutical Research and Development

    • 1st Edition
    • Hiroyuki Ohshima + 1 more
    • English
    Colloid and Interface Science in Pharmaceutical Research and Development describes the role of colloid and surface chemistry in the pharmaceutical sciences. It gives a detailed account of colloid theory, and explains physicochemical properties of the colloidal-pharmaceut... systems, and the methods for their measurement. The book starts with fundamentals in Part I, covering fundamental aspects of colloid and interface sciences as applied to pharmaceutical sciences and thus should be suitable for teaching. Parts II and III treat applications and measurements, and they explains the application of these properties and their influence and use for the development of new drugs.

  • Alkyl Polyglucosides

    From Natural-origin Surfactants to Prospective Delivery Systems
    • 1st Edition
    • Ivana Pantelic
    • English
    The on-going ‘green’ trend in the personal care industry coupled with global environmental concerns, place natural-origin, biodegradable and skin-friendly surfactants such as alkyl polyglucosides (APGs) in high demand. After successful use in cosmetics, sufficient data has been obtained to welcome some sugar emulsifiers into the field of drug dosage. Alkyl Polyglucosides presents a comprehensive compendium which guides a researcher from the APG-related preformulation stages to formulation processing, including the investigation of various APG-stabilized systems skin performance. This book introduces various APG representatives, their benefits in relation to certain conventional surfactants, physicochemical and interfacial properties, possible interaction with commonly used ingredients and diverse characterization techniques indispensable for the assessment of colloidal systems. The first chapter introduces alkyl polyglucosides, followed by chapters on their properties, behaviour, an overview of the patent protection mechanisms and guidelines for submitting patent applications. Finally, a conclusion surveys international patent applications involving APGs.

  • The Quality Control of Medicines

    Proceedings of the 35th International Congress of Pharmaceutical Sciences, Dublin, 1975
    • 1st Edition
    • P.B. Deasy + 1 more
    • English
    The Quality Control of Medicines documents the proceedings of the 35th International Congress of Pharmaceutical Sciences, organized by the Pharmaceutical Society of Ireland on behalf of the Federation Internationale Pharmaceutique, held in Dublin, on 1-5 September 1975. The theme chosen for the Congress was ""the basis for the quality control of medicines"", because of the importance and relevance of quality control in the production and distribution of medicines at national and international levels. This volume is arranged according to the manner in which the theme of the Congress was developed by the eminent invited speakers. Following the inaugural address a main symposium was held where five speakers presented a review of the quality control of medicines under the general headings of (i) chemical and physical aspects; (ii) biological aspects; (iii) control of drug delivery systems; (iv) storage problems; and (v) problems of international control. Certain aspects of the content of the main symposium were then developed in greater depth in parallel symposia. In the first parallel symposium some novel physicochemical aspects of the quality control of medicines were treated under the headings of spectrofluorimetry, mass spectrometry, detection in gas chromatography, and automation in pharmaceutical analysis. The second parallel symposium developed certain microbiological aspects of quality control under the headings of sterility testing and microbiological control of non-sterile products and ophthalmic preparations. The final symposium on submissions to regulatory bodies and international aspects of drug control covered aspects of politics in submissions, regulatory problems in small countries, and various pharmacopoeial problems.

  • Parenteral Products

    The Preparation and Quality Control of Products for Injection
    • 1st Edition
    • M. J. Groves
    • English
    Parenteral Products: The Preparation and Quality Control of Products for Injection deals with modern pharmaceutical practice in the preparation, quality control, and storage of injectable drug solutions. The book gives a basic background of parenteral solutions, the routes of administration, the effects of the different administrations of injection solutions, and the formulation of these products. The text discusses the theories of filtration, the different methods used, such as screen filters, depth filters, and the possible choices of filtration to capture any preselected unwanted particle size. Developments on sterilization of the product are given attention, citing techniques and equipment. The working and preparation conditions are discussed, since the sterile intravenous solutions, whether in large or small quantities, are done in quite the same procedures, with the similar equipment, and same organization. Equally important in the discussion are the monitoring and control of contamination by particulates through the application of standards known as the Coulter principle and the light-blockage method. The pharmaceutical problems encountered during the administration of large volume drip solutions are analyzed. This book is helpful for pharmacists, pharmaceutical students and professors, and those working in the pharmaceutical industry and hospital/health sector.

  • Profiles of Drug Substances, Excipients and Related Methodology

    • 1st Edition
    • Volume 39
    • Harry G. Brittain
    • English
    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.

  • PROP - Foundation of Pharmaceutical Care Custom Text

    • 1st Edition
    • Anthem
    • English

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Pharma's Prescription

    How the Right Technology Can Save the Pharmaceutical Business
    • 1st Edition
    • Kamal Biswas
    • English
    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.

  • Pharmaceutics

    Basic Principles and Application to Pharmacy Practice
    • 1st Edition
    • Alekha Dash + 1 more
    • English
    Pharmaceutics: Basic Principles and Application to Pharmacy Practice is an engaging textbook that covers all aspects of pharmaceutics with emphasis on the basic science and its application to pharmacy practice. Based on curricular guidelines mandated by the American Council for Pharmacy Education (ACPE), this book incorporates laboratory skills by identifying portions of each principle that can be used in a clinical setting. In this way, instructors are able to demonstrate their adherence to ACPE standards and objectives, simply by using this book. Written in a straightforward and student-friendly manner, Pharmaceutics enables students to gain the scientific foundation to understand drug physicochemical properties, practical aspects of dosage forms and drug delivery systems, and the biological applications of drug administration. Key ideas are illustrated and reinforced through chapter objectives and chapter summaries. A companion website features resources for students and instructors, including videos illustrating difficult processes and procedures as well as practice questions and answers. Instructor resources include Powerpoint slides and a full-color image bank. This book is intended for students in pharmaceutical science programs taking pharmaceutics or biopharmaceutics courses at the undergraduate, graduate and doctoral level.

  • Cancer Drug Design and Discovery

    • 2nd Edition
    • Stephen Neidle
    • English
    Cancer Drug Design and Discovery, Second Edition is an important reference on the underlying principles for the design and subsequent development of new anticancer small molecule agents. New chapters have been added to this edition on areas of particular interest and therapeutic promise, including cancer genomics and personalized medicine, DNA-targeted agents and more. This book includes several sections on the basic and applied science of cancer drug discovery and features those drugs that are now approved for human use and are in the marketplace, as well as those that are still under development. By highlighting some of the general principles involved in taking molecules through basic science to clinical development, this book offers a complete and authoritative reference on the design and discovery of anticancer drugs for translational scientists and clinicians involved in cancer research.

  • Formulation Tools for Pharmaceutical Development

    • 1st Edition
    • J E Aguilar
    • English
    A range of new and innovative tools used for preformulation and formulation of medicines help optimize pharmaceutical development projects. Such tools also assist with the performance evaluation of the pharmaceutical process, allowing any potential gaps to be identified. These tools can be applied in both basic research and industrial environment. Formulation tools for pharmaceutical development considers these key research and industrial tools.Nine chapters by leading contributors cover: Artificial neural networks technology to model, understand, and optimize drug formulations; ME_expert 2.0: a heuristic decision support system for microemulsions formulation development; Expert system for the development and formulation of push-pull osmotic pump tablets containing poorly water-soluble drugs; SeDeM Diagram: an expert system for preformulation, characterization and optimization of tables obtained by direct compression; New SeDeM-ODT expert system: an expert system for formulation of orodispersible tablets obtained by direct compression; and 3D-cellular automata in computer-aided design of pharmaceutical formulations: mathematical concept and F-CAD software.

  • Mosby's Review for the Pharmacy Technician Certification Examination

    • 3rd Edition
    • James J. Mizner
    • English
    Covering everything you need to study for and pass the Pharmacy Technician Certification Board (PTCB) and ExCPT exams, Mosby's Review for the Pharmacy Technician Certification Examination, 3rd Edition makes exam preparation easy. Review the content you'll see on the exam with handy outlines, test-taking tips and strategies, and electronic flash cards. Written by noted pharmacy technician educator James J. Mizner, this complete review tests your knowledge and simulates the actual PTCB exam with 17 different, 100-question practice exams in the book and online. This edition is modeled after the updated Pharmacy Technician Certification Exam Blueprint.

  • Workbook for Pharmacy Practice Today for the Pharmacy Technician

    Career Training for the Pharmacy Technician
    • 1st Edition
    • LiAnne C. Webster
    • English
    Reinforce your knowledge of the pharmacy technician role, and prepare for certification exams! Corresponding to the chapters in Pharmacy Practice for Today’s Pharmacy Technician: Career Training for the Pharmacy Technician, by LiAnne Webster, this practical workbook offers a wide variety of review questions relating to essential pharmacy technician tasks and skills. Critical thinking exercises help you apply what you’ve learned to real-life situations in pharmacy practice.

  • The Path from Biomarker Discovery to Regulatory Qualification

    • 1st Edition
    • Federico Goodsaid + 1 more
    • English
    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...

  • Pharmacy Practice Today for the Pharmacy Technician

    Career Training for the Pharmacy Technician
    • 1st Edition
    • LiAnne C. Webster
    • English
    Covering everything from certification exam review to key skills, Pharmacy Practice for Today’s Pharmacy Technician: Career Training for the Pharmacy Technician covers all of the knowledge needed by pharmacy technicians to provide exemplary patient care and build a successful career. It describes the role of the pharmacy technician in different practice settings, including the key tasks and skills set required to work in a community pharmacy, institutional pharmacy, or home health and long-term care/hospice care, then adds a road map taking you through certification, the job search, interviewing, and continuing education. Written by pharmacy technician educator and expert LiAnne Webster, this comprehensive text prepares you to succeed in this rapidly growing field.

  • Quality Assurance

    Problem Solving and Training Strategies for Success in the Pharmaceutical and Life Science Industries
    • 1st Edition
    • G Welty
    • English
    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.

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

    • 1st Edition
    • Lisa M. Plitnick + 1 more
    • English
    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.

  • The School of Pharmacy, University of London

    Medicines, Science and Society, 1842-2012
    • 1st Edition
    • Briony Hudson + 1 more
    • English
    The School of Pharmacy, University of London: Medicines, Science and Society, 1842-2012 represents the rich history of the University of London School of Pharmacy through numerous color photographs, important advances in the pharmacy profession, cultural milestones, biographies and more. Written in an engaging and authoritative style, this book depicts the chronological history of the school from its establishment in 1842 to the present day with a nod toward its aspirations for the future. By highlighting key periods in the school’s history and showing their connection to the wider world, this book truly commemorates the heritage of the School of Pharmacy and its cutting-edge role in pharmacy innovation, research and education.

  • The Future of Drug Discovery

    Who Decides Which Diseases to Treat?
    • 1st Edition
    • Tamas Bartfai + 1 more
    • English
    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.

  • Profiles of Drug Substances, Excipients, and Related Methodology

    • 1st Edition
    • Volume 38
    • Harry G. Brittain
    • English
    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.

  • Inhaler Devices

    Fundamentals, Design and Drug Delivery
    • 1st Edition
    • Polina Prokopovich
    • English
    Given their direct impact on the health and quality of life for millions, inhalers represent a major turning point in the history of modern medicine. Inhaler devices: Fundamentals, design and drug delivery provides readers with an introduction to the fundamentals of inhaler technology, with a comprehensive discussion of the history of inhalers as well as a discussion on current research and development.Part one discusses the fundamentals and development of inhaler devices as well as drug formulations for inhalers. The treatment of asthma is also discussed. Part two reviews recent developments in drug formulation and nanotechnology for inhaler devices, emerging inhaler technology and possible future trends.Inhaler devices: Fundamentals, design and drug delivery is an essential design guide for good industrial practice, and will be an invaluable resource for those researching and treating conditions such as asthma; and those developing and manufacturing inhalation devices.

  • Pharmacy Law and Practice

    • 5th Edition
    • Jon Merrills + 1 more
    • English
    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.

  • Computer-Aided Applications in Pharmaceutical Technology

    • 1st Edition
    • Jelena Duris
    • English
    Research and development in the pharmaceutical industry is a time-consuming and expensive process, making it difficult for newly developed drugs to be formulated into commercially available products. Both formulation and process development can be optimized by means of statistically organized experiments, artificial intelligence and other computational methods. Simultaneous development and investigation of pharmaceutical products and processes enables application of quality by design concept that is being promoted by the regulatory authorities worldwide. Computer-Aided Applications in Pharmaceutical Technology covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with emphasis of their application in process control, neural computing (artificial neural networks, fuzzy logic and decision trees, evolutionary computing and genetic algorithms, self-organizing maps), computer-aided biopharmaceutical characterization as well as application of computational fluid dynamics in pharmaceutical technology. All of these techniques are essential tools for successful building of quality into pharmaceutical products and processes from the early stage of their development to selection of the optimal ones. In addition to theoretical aspects of various methods, the book provides numerous examples of their application in the field of pharmaceutical technology.

  • Nonclinical Study Contracting and Monitoring

    A Practical Guide
    • 1st Edition
    • William F. Salminen + 2 more
    • English
    Nonclinical Study Contracting and Monitoring: A Practical Guide offers a systematic and straightforward handbook for obtaining high quality preclinical Good Laboratory Practice (GLP) studies. This book is full of real-world examples, processes, procedures, useful templates, checklists and sample reports to provide readers with a better understanding of exactly what happens during all stages of a GLP study and the critical aspects of GLP study design and conduct. Designed for both the novice and experienced scientist, this book covers the GLP regulations and how they impact preclinical studies, the differences between GLP, non-GLP and peer-reviewed studies, preclinical GLP study design, laboratory selection, contracts and business ethics, how to obtain test material for the study, animal sourcing and release for study, preparation of a draft report and much more. By illustrating the overall big picture and tying it together with the individual steps, this book is an essential resource to help scientists ensure a high quality GLP study that passes both scientific and regulatory scrutiny.

  • Workbook for Pharmacology for Pharmacy Technicians

    • 2nd Edition
    • Kathy Moscou + 1 more
    • English
    Specially designed to parallel the material in Pharmacology for Pharmacy Technicians, 2nd Edition, this helpful workbook provides in-depth study and review of the ASHP content requirements for pharmacology and anatomy and physiology. Its user-friendly format and engaging learning exercises help you understand both basic and advanced pharmacologic concepts. Practical activities allow you to apply your knowledge to real-world scenarios.

  • Actinomycetes in Biotechnology

    • 1st Edition
    • Bozzano G Luisa
    • English
    The actinomycetes are a group of bacteria well known as producers of antibiotics. With the advent of molecular biology they have become important to biotechnologists in the search for new antibiotics, vitamins, enzyme inhibitors, etc. They also play an important role in the biodegradation of wastes, and their wide (natural) distribution in soil, composts, water and elsewhere in the environment makes them important to the agricultural and waste industries. This research book presents a broad view of the current interest in actinomycetes, ranging from isolation/screening of actinomycetes, discovery of new antibiotics, a substantial contribution on genetic manipulation to actinomycetes in agriculture, forestry, and the threat of actinomycetes as pollutants in the environment.The chapters, which have been written by experts, are intended to provide a balanced view of the opportunities and problems in an expanding field of interest.

  • Histone Deacetylase Inhibitors as Cancer Therapeutics

    • 1st Edition
    • Volume 116
    • English
    Advances in Cancer Research provides invaluable information on the exciting and fast-moving field of cancer research. This thematic volume looks at "Histone Deacetylase Inhibitors as Cancer Therapeutics."

  • Contract Research and Manufacturing Services (CRAMS) in India

    The Business, Legal, Regulatory and Tax Environment in the Pharmaceutical and Biotechnology Sectors
    • 1st Edition
    • Milind Antani + 1 more
    • English
    The field of contract research and manufacturing broadly encompasses those services in the pharmaceutical and biotechnology sectors that require extensive research and development and large-scale manufacturing facilities. The field has great potential for growth in the Indian outsourcing industry, which is world-renowned for its provision of cheap and highly-skilled services. Contract research and manufacturing services (CRAMS) in India provides a detailed account of the current scenario in India and the advantages that the Indian outsourcing industry can offer in the field of CRAMS. Following an overview of the services and their emergence in India, chapters in the book begin by discussing the legal and regulatory scenario and major concerns and issues. In the latter part of the book, topics covered include service agreements, dispute resolution and contract negotiations, followed by a discussion of the outlook for CRAMS in India and some concluding remarks. Several appendices are included, offering a list of major players in the field and various forms for use in licence applications.

  • Lead Compounds from Medicinal Plants for the Treatment of Cancer

    • 1st Edition
    • Christophe Wiart
    • English
    Lead Compounds from Medicinal Plants for the Treatment of Cancer is the first volume in the series, Pharmaceutical Leads from Medicinal Plants. The plant species described in this reference have been carefully selected based on pharmacological evidence and represent today’s most promising sources of natural products for the discovery of anti-cancer drugs. Containing references to primary source material, over a hundred botanical illustrations, a table of chemical structures and much more, this book is an essential starting point for cancer researchers and those involved in anti-cancer drug discovery helping you identify the best novel lead molecules for further anti-cancer drug development.

  • A Comprehensive Guide to Toxicology in Preclinical Drug Development

    • 1st Edition
    • Ali S. Faqi
    • English
    A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing.

  • Progress in Medicinal Chemistry

    • 1st Edition
    • Volume 51
    • English
    Progress in Medicinal Chemistry provides a review of eclectic developments in medicinal chemistry. This volume continues in the serial's tradition of providing an insight into the skills required of the modern medicinal chemist; in particular, the use of an appropriate selection of the wide range of tools now available to solve key scientific problems.

  • Profiles of Drug Substances, Excipients and Related Methodology

    • 1st Edition
    • Volume 37
    • Harry G. Brittain
    • English
    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.

  • Therapeutic Protein Drug Products

    Practical Approaches to formulation in the Laboratory, Manufacturing, and the Clinic
    • 1st Edition
    • Brian K Meyer
    • English
    Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. A brief section on biophysical and analytical analysis is also provided. Properties of therapeutic protein formulations are described and include opalescence, phase separation, color, and subvisible particles. An emphasis is placed on material and process testing to ensure success during manufacturing. The drug product manufacturing process, which includes the process of compounding to filling, is also covered. Methods of delivery in the clinic are addressed, as well as delivery strategies. Finally, a perspective on the regulatory requirements for therapeutic protein formulations is discussed.

  • Mosby's Pharmacy Technician Lab Manual Revised Reprint

    • 1st Edition
    • Judith Neville
    • English
    This comprehensive lab manual features more than 49 practical exercises that provide hands-on training for essential pharmacy technician skills. Realistic lab exercises include illustrations of prescription orders, and cover concepts such as hand hygiene, counting medication, prescription interpretation, data entry, pharmacy conversions, inventory management, and prior authorization. Perforated pages make it easy to turn in exercises for evaluation.

  • Clinical Trials

    Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines
    • 1st Edition
    • Tom Brody
    • English
    Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design.

  • Pharmacy Management Software for Pharmacy Technicians: A Worktext

    • 2nd Edition
    • DAA Enterprises, Inc.
    • English
    Gain a head start on your career as a pharmacy technician with Pharmacy Management Software for Pharmacy Technicians, 2nd Edition. This innovative software/worktext package incorporates the full version of real 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. Easy-to-follow, step-by-step instructions guide you through entering patient data, prescription/medicat... orders, and insurance information, reviewing inventory, and more, enabling you to acquire the skills and experience for professional success before you leave the classroom!

  • An Introduction to Pharmaceutical Sciences

    Production, Chemistry, Techniques and Technology
    • 1st Edition
    • Jiben Roy
    • English
    This textbook is written as a unified approach to various topics, ranging from drug discovery to manufacturing, techniques and technology, regulation and marketing. The key theme of the book is pharmaceuticals - what every student of pharmaceutical sciences should know: from the active pharmaceutical ingredients to the preparation of various dosage forms along with the relevant chemistry, this book makes pharmaceuticals relevant to undergraduate students of pharmacy and pharmaceutical sciences.This book explains how a particular drug was discovered and then converted from lab-scale to manufacturing scale, to the market. It explains the motivation for drug discovery, the reaction chemistry involved, experimental difficulties, various dosage forms and the reasoning behind them, mechanism of action, quality assurance and role of regulatory agencies. After having a course based on this book, the student will be able to understand: 1) the career prospects in the pharmaceutical industry, 2) the need for interdisciplinary teamwork in science, 3) the techniques and technology involved in making pharmaceuticals starting from bulk drugs, and 4) different dosage forms and critical factors in the development of pharmaceutical formulations in relation to the principles of chemistry.A few blockbuster drugs including atorvastatin, sildanefil, ranitidine, ciprofloxacin, amoxicillin, and the longest serving drugs such as aspirin and paracetamol are discussed in detail. Finally, the book also covers the important current pharmaceutical issues like quality control, safety, counterfeiting and abuse of drugs, and future prospects for pharmaceutical industry.

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