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Elsevier

Libros en Ciencias Farmacéuticas

  • Inorganic Controlled Release Technology

    Materials and Concepts for Advanced Drug Formulation
    • 1 Edición
    • Xiang Zhang + 1 más
    • Inglés
    Inorganic Controlled Release Technology: Materials and Concepts for Advanced Drug Formulation provides a practical guide to the use and applications of inorganic controlled release technology (iCRT) for drug delivery and other healthcare applications, focusing on newly developed inorganic materials such as bioresorbable glasses and bioceramics. The use of these materials is introduced for a wide range of applications that cover inorganic drug delivery systems for new drug development and the reformulation of existing drugs. The book describes basic concepts, principles, and industrial practices by discussing materials chemistry, physics, nano/microstructure, formulation, materials processing, and case studies, as well as the evaluation and characterization of iCRT systems commonly investigated during industrial R&D.

  • Nonclinical Assessment of Abuse Potential for New Pharmaceuticals

    • 1 Edición
    • Carrie Markgraf + 2 más
    • Inglés
    Nonclinical Assessment of Abuse Potential for New Pharmaceuticals offers a complete reference on the current international regulatory guidelines and details best practice methodology for the three standard animal models used to evaluate abuse potential: physical dependence, self-administration and drug discrimination. This book also includes chapters on alternative models and examples of when you should use these alternatives. Case histories are provided at the end of the book to show how the data generated from the animal models play a pivitol role in the submission package for a new drug. By incorporating all of this information into one book, Nonclinical Assessment of Abuse Potential for New Pharmaceuticals is your single resource for everything you need to know to understand and implement the assessment of abuse liability.

  • Prodrug Design

    Perspectives, Approaches and Applications in Medicinal Chemistry
    • 1 Edición
    • Vivekkumar K Redasani + 1 más
    • Inglés
    Prodrug Design: Perspectives, Approaches and Applications in Medicinal Chemistry provides a focused overview of this critical area of drug discovery, as that continuous process strives not only to discover new drug compounds but also to modify the existing ones. This valuable primer supports this mission of drug development and its goal of reducing undesired effects and improving therapeutic effectiveness of drug compounds. Providing a unique compilation of data, insightful case studies, and review of existing literature in the area, the book will promote innovation in medicinal and pharmaceutical chemistry research, exploring the limitations of existing drugs and their improvement. Prodrug Design reviews marketed compounds, the safety of promoieties, and a detailed classification of prodrugs organized by therapeutic area for easy reference.

  • Strategies to Modify the Drug Release from Pharmaceutical Systems

    • 1 Edición
    • Marcos Luciano Bruschi
    • Inglés
    Since the earliest dosage forms to modern drug delivery systems, came a great development and growth of knowledge with respect to drug delivery. Strategies to Modify the Drug Release from Pharmaceutical Systems will address principles, systems, applications and advances in the field.It will be principally a textbook and a reference source of strategies to modify the drug release. Moreover, the characterization, mathematical and physicochemical models, applications and the systems will be discussed.

  • Drug Design and Discovery in Alzheimer’s Disease

    • 1 Edición
    • Atta-ur Rahman + 1 más
    • Inglés
    Drug Design and Discovery in Alzheimer’s Disease includes expert reviews of recent developments in Alzheimer's disease (AD) and neurodegenerative disease research. Originally published by Bentham as Frontiers in Drug Design and Discovery, Volume 6and now distributed by Elsevier, this compilation of the sixteen articles, written by leading global researchers, focuses on key developments in the understanding of the disease at molecular levels, identification and validation of molecular targets, as well as innovative approaches towards drug discovery, development, and delivery. Beginning with an overview of AD pharmacotherapy and existing blockbuster drugs, the reviews cover the potential of both natural and synthetic small molecules; the role of cholinesterases in the on-set and progression of AD and their inhibition; the role of beta-site APP clearing enzyme-1 (BACE-1) in the production of β-amyloid proteins, one of the key reasons of the progression of AD; and other targets identified for AD drug discovery.

  • Profiles of Drug Substances, Excipients and Related Methodology

    • 1 Edición
    • Volumen 40
    • Inglés
    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.

  • Basic Principles of Drug Discovery and Development

    • 1 Edición
    • Benjamin E. Blass
    • Inglés
    Basic Principles of Drug Discovery and Development presents the multifaceted process of identifying a new drug in the modern era, providing comprehensive explanations of enabling technologies such as high throughput screening, structure based drug design, molecular modeling, pharmaceutical profiling, and translational medicine, all areas that have become critical steps in the successful development of marketable therapeutics. The text introduces the fundamental principles of drug discovery and development, also discussing important drug targets by class, in vitro screening methods, medicinal chemistry strategies in drug design, principles in pharmacokinetics and pharmacodynamics, animal models of disease states, clinical trial basics, and selected business aspects of the drug discovery process. It is designed to enable new scientists to rapidly understand the key fundamentals of drug discovery, including pharmacokinetics, toxicology, and intellectual property."

  • The Science and Ethics of Antipsychotic Use in Children

    • 1 Edición
    • Nina Di Pietro + 1 más
    • Inglés
    The Science and Ethics of Antipsychotic Use in Children reviews the latest findings for the safety and efficacy of the rapidly rising incidence of antipsychotic use in children and examines tensions that are created by off-label use, both in clinical psychiatric practice and research.In the past ten years, the number of antipsychotics prescribed to children with psychiatric disorders has skyrocketed. Despite this rapid growth, most medications have been inadequately studied in children for safety or efficacy and many have serious adverse health. Measures are needed to ensure that the health and safety of children are being protected, and debates have emerged over whether or not clinical trials in this population should be conducted.

  • Principles of Translational Science in Medicine

    From Bench to Bedside
    • 2 Edición
    • Martin Wehling
    • Inglés
    Principles of Translational Science in Medicine: From Bench to Bedside, Second Edition, provides an update on major achievements in the translation of research into medically relevant results and therapeutics. The book presents a thorough discussion of biomarkers, early human trials, and networking models, and includes institutional and industrial support systems. It also covers algorithms that have influenced all major areas of biomedical research in recent years, resulting in an increasing numbers of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine.

  • The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment

    • 1 Edición
    • Joerg Bluemel + 3 más
    • Inglés
    The Nonhuman Primate in Drug Development and Safety Assessment is a valuable reference dedicated to compiling the latest research on nonhuman primate models in nonclinical safety assessment, regulatory toxicity testing and translational science. By covering important topics such as study planning and conduct, inter-species genetic drift, pathophysiology, animal welfare legislation, safety assessment of biologics and small molecules, immunotoxicology and much more, this book provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing. A comprehensive yet practical guide, this book is intended for new researchers or practicing toxicologists, toxicologic pathologists and pharmaceutical scientists working with nonhuman primates, as well as graduate students preparing for careers in this area.

  • Understanding the Basics of QSAR for Applications in Pharmaceutical Sciences and Risk Assessment

    • 1 Edición
    • Kunal Roy + 2 más
    • Inglés
    Understanding the Basics of QSAR for Applications in Pharmaceutical Sciences and Risk Assessment describes the historical evolution of quantitative structure-activity relationship (QSAR) approaches and their fundamental principles. This book includes clear, introductory coverage of the statistical methods applied in QSAR and new QSAR techniques, such as HQSAR and G-QSAR. Containing real-world examples that illustrate important methodologies, this book identifies QSAR as a valuable tool for many different applications, including drug discovery, predictive toxicology and risk assessment. Written in a straightforward and engaging manner, this is the ideal resource for all those looking for general and practical knowledge of QSAR methods.

  • Evidence-Based Validation of Herbal Medicine

    • 1 Edición
    • Pulok K. Mukherjee
    • Inglés
    Evidence-Based Validation of Herbal Medicines brings together current thinking and practice in the areas of characterization and validation of natural products. This book reviews all aspects of evaluation and development of medicines from plant sources, including their cultivation, collection, phytochemical and phyto-pharmacologica... evaluation, and therapeutic potential. Emphasis is placed on describing the full range of evidence-based analytical and bio-analytical techniques used to characterize natural products, including –omic technologies, phyto-chemical analysis, hyphenated techniques, and many more.

  • Cannabinoids in Neurologic and Mental Disease

    • 1 Edición
    • Liana Fattore
    • Inglés
    The application of cannabis sativa for the treatment of neurologic and mental disease is expanding. Cannabinoids in Neurologic and Mental Disease collects and presents for the first time recent research involving the use of pharmacological cannabinoids for the treatment of neurodegenerative and neuroinflammatory disease. The neurologic application of cannabinoid therapy builds upon psychiatric and psychological use for the treatment of a variety of core mental disorders. This comprehensive reference on the known uses of cannabinoids will be useful for clinical neurologists, neuroscience and clinical neuroscience researchers, clinical psychologists and psychiatrists and the general medical community.

  • Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies

    • 1 Edición
    • Manmohan Singh + 1 más
    • Inglés
    Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies takes a look at the current strategies, successes and challenges involved with the development of novel formulations of biologics, vaccines and cancer therapy. This thorough reference on the latest trends in the development of diverse modalities will appeal to a broad community of scientists, students and clinicians. Written by leading authors across academia and industry, this book covers important topics such as unique drug delivery devices, non-parenteral delivery trends, novel approaches to the treatment of cancer, immunotherapy and more. It includes real-world cases and examples which highlight formulations with therapeutic proteins, monoclonal antibodies, peptides and biobetters, as well as cases on novel vaccines formulations including evolving pathogens, novel modalities of vaccines, universal vaccines. This book is a thorough and useful resource on the development of novel biologics, vaccines and cancer therapies.

  • Controlled Drug Delivery

    The Role of Self-Assembling Multi-Task Excipients
    • 1 Edición
    • M A Mateescu + 2 más
    • Inglés
    In complex macromolecules, minor modifications can generate major changes, due to self-assembling capacities of macromolecular or supramolecular networks. Controlled Drug Delivery highlights how the multifunctionality of several materials can be achieved and valorized for pharmaceutical and biopharmaceutical applications. Topics covered in this comprehensive book include: the concept of self-assembling; starch and derivatives as pharmaceutical excipients; and chitosan and derivatives as biomaterials and as pharmaceutical excipients. Later chapters discuss polyelectrolyte complexes as excipients for oral administration; and natural semi-synthetic and synthetic materials. Closing chapters cover protein-protein associative interactions and their involvement in bioformulations; self-assembling materials, implants and xenografts; and provide conclusions and perspectives.

  • The History of the Gamma Knife

    • 1 Edición
    • Volumen 215
    • Jeremy C. Ganz
    • Inglés
    The History of the Gamma Knife presents the evolution of concepts and technology which ended in the production of the modern Gamma Knife. The story starts before the Second World War and links pioneers in Berkeley and Sweden. To the best of the author’s belief it is the first detailed, factually accurate account of the development of this important therapeutic method.

  • Innovative Brain Tumor Therapy

    • 1 Edición
    • Gerardo Caruso + 2 más
    • Inglés
    Despite recent advances, therapeutic efforts have not been successful establishing a definitive strategy of treatment for brain gliomas, because of the presence of the blood-brain barrier. Innovative Brain Tumor Therapy presents a synopsis of the studies on nanoparticles as ideal devices for brain tumor treatment. Their nanometric size, electrostatic charge, and lipophilic characteristics allow them to penetrate into the brain tissue freely. Promising in-vitro results have been reported, but remain to be validated in humans. This title focuses on the blood-brain barrier pathophysiology in brain tumors, and the possibilities of overcoming this with nanoparticle-based systems. Relevant patents of nanoparticles used as drug delivery carriers are also reported, as well as future scenarios in nanoparticles and stem cells.

  • Design and Manufacture of Pharmaceutical Tablets

    • 1 Edición
    • Reynir Eyjolfsson
    • Inglés
    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.

  • Pharmacology of the Blood Brain Barrier: Targeting CNS Disorders

    • 1 Edición
    • Volumen 71
    • Inglés
    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

    • 1 Edición
    • K Y Heng + 5 más
    • Inglés
    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.

  • Colloid and Interface Science in Pharmaceutical Research and Development

    • 1 Edición
    • Hiroyuki Ohshima + 1 más
    • Inglés
    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
    • 1 Edición
    • Ivana Pantelic
    • Inglés
    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
    • 1 Edición
    • P.B. Deasy + 1 más
    • Inglés
    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
    • 1 Edición
    • M. J. Groves
    • Inglés
    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

    • 1 Edición
    • Volumen 39
    • Harry G. Brittain
    • Inglés
    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.

  • Predictive Modeling of Pharmaceutical Unit Operations

    • 1 Edición
    • Preetanshu Pandey + 1 más
    • Inglés
    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

    • 1 Edición
    • Volumen 69
    • Linda P. Dwoskin
    • Inglés
    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

    • 1 Edición
    • Christophe Wiart
    • Inglés
    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
    • 1 Edición
    • Pierre-Louis Lezotre
    • Inglés
    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.

  • Ocular Transporters and Receptors

    Their Role in Drug Delivery
    • 1 Edición
    • Ashim K Mitra
    • Inglés
    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.

  • Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

    Technology, Validation and Current Regulations
    • 1 Edición
    • Tim Sandle
    • Inglés
    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.

  • Formulation Tools for Pharmaceutical Development

    • 1 Edición
    • J E Aguilar
    • Inglés
    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.

  • Cancer Drug Design and Discovery

    • 2 Edición
    • Stephen Neidle
    • Inglés
    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.

  • Mosby's Review for the Pharmacy Technician Certification Examination

    • 3 Edición
    • James J. Mizner
    • Inglés
    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
    • 1 Edición
    • LiAnne C. Webster
    • Inglés
    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

    • 1 Edición
    • Federico Goodsaid + 1 más
    • Inglés
    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
    • 1 Edición
    • LiAnne C. Webster
    • Inglés
    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
    • 1 Edición
    • G Welty
    • Inglés
    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

    • 1 Edición
    • Lisa M. Plitnick + 1 más
    • Inglés
    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.

  • Profiles of Drug Substances, Excipients, and Related Methodology

    • 1 Edición
    • Volumen 38
    • Harry G. Brittain
    • Inglés
    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.

  • Computer-Aided Applications in Pharmaceutical Technology

    • 1 Edición
    • Jelena Duris
    • Inglés
    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
    • 1 Edición
    • William F. Salminen + 2 más
    • Inglés
    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

    • 2 Edición
    • Kathy Moscou + 1 más
    • Inglés
    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.

  • Histone Deacetylase Inhibitors as Cancer Therapeutics

    • 1 Edición
    • Volumen 116
    • Inglés
    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."

  • Lead Compounds from Medicinal Plants for the Treatment of Cancer

    • 1 Edición
    • Christophe Wiart
    • Inglés
    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.

  • Mosby's Pharmacy Technician Lab Manual Revised Reprint

    • 1 Edición
    • Judith Neville
    • Inglés
    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.

  • Pharmacy Management Software for Pharmacy Technicians: A Worktext

    • 2 Edición
    • DAA Enterprises, Inc.
    • Inglés
    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
    • 1 Edición
    • Jiben Roy
    • Inglés
    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.

  • Outsourcing Biopharma R&D to India

    • 1 Edición
    • P R Chowdhury
    • Inglés
    The trend of outsourcing to India for research and development is catching on fast. Over the last decade, worldwide pharmaceutical and biotechnology companies have made India their choice for a research destination. Initially R&D was inclined more towards developing products for the Indian market within the country. This led to several multinational companies opening up production plants in India, primarily due to the globalization of the Indian economy and offshoring jobs to India. Alongside, several global pharma-biotech majors ascertained large market requirements within the country and capitalized on the advantage of serving Indian customers. Strategies were devised to optimize operational expenses with the setting up of on-site R&D to develop products for local requirements. In view of this, this book seeks to explore various nuances of the outsourcing sector with respect to biopharma in India.

  • The Brain as a Drug Target

    • 1 Edición
    • Volumen 98
    • Shafiqur Rahman
    • Inglés
    The brain is protected by the blood-brain barrier and this barrier prevents many drugs from entering the brain. This volume discusses various drug delivery and targeting strategies that are being developed to enhance the transport and distribution of drugs into the brain.

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