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Books > Business & Economics > Industry & industrial studies > Manufacturing industries > Pharmaceutical industries

Illicit Medicines in the Global South - Public Health Access and Pharmaceutical Regulation (Hardcover): Mathieu Quet Illicit Medicines in the Global South - Public Health Access and Pharmaceutical Regulation (Hardcover)
Mathieu Quet
R3,914 Discovery Miles 39 140 Ships in 12 - 17 working days

This book investigates pharmaceutical regulation and the public health issue of fake or illicit medicines in developing countries. The book analyses the evolution of pharmaceutical capitalism, showing how the entanglement of market and health interests has come to shape global regulation. Drawing on extensive fieldwork in India, Kenya, and Europe, it demonstrates how large pharmaceutical companies have used the fight against fake medicines to serve their strategic interests and protect their monopolies, sometimes to the detriment of access to medicines in developing countries. The book investigates how the contemporary dynamics of pharmaceutical power in global markets have gone on to shape societies locally, resulting in more security-oriented policies. These processes highlight the key consequences of contemporary "logistical regimes" for access to health. Providing important insights on how the flows of commodities, persons, and knowledge shape contemporary access to medicines in the developing countries, this book will be of considerable interest to policy makers and regulators, and to scholars and students across sociology, science and technology studies, global health, and development studies.

Pharmaceutical Supply Chain - Drug Quality and Security Act (Paperback): Fred A Kuglin Pharmaceutical Supply Chain - Drug Quality and Security Act (Paperback)
Fred A Kuglin
R1,028 Discovery Miles 10 280 Ships in 12 - 17 working days

Error-proofing in the production process of pharmaceuticals isn't just a matter of good business, it has life-and-death implications for consumers. To that end, the 2013 Drug Quality and Security Act in large part requires new mandates on tracking and tracing chain of custody in the supply chain. Pharmaceutical Supply Chain: Drug Quality and Security Act overviews the new mandate and its implications, including implementation strategies for track-and-trace programs along with presenting a fuller understanding of the mechanics of intergovernmental policies and oversights. The book focuses on the delicate balance between protecting the public through legislation against negligent compounding pharmacies and protecting patients by assuring a supply of needed compounded drugs by not over-regulating the industry. The author discusses lessons learned from the earlier e-pedigree initiatives, the technology advances that enable supply chain security, and how the industry will need to respond to the myriad of threats facing the pharmaceutical drug supply chain and comply with this act. He goes in depth into each segment of the pharmaceutical drug supply chain, describing the industry segment and how it will need to adapt to the new act. By incorporating real-world examples of industry leaders, the book underlines the contributions of individuals who have made a difference through innovations and execution. It also addresses how laws are made, and specifically how the Drug Quality and Security Act was passed by Congress and signed into law. In an industry that is so big, you may feel that you cannot make a difference. This book provides you with key insights on how the forward supply chain process should work and how anyone can make a difference at all levels.

Raising Lazarus - Hope, Justice, and the Future of America's Overdose Crisis (Hardcover): Beth Macy Raising Lazarus - Hope, Justice, and the Future of America's Overdose Crisis (Hardcover)
Beth Macy
R914 R812 Discovery Miles 8 120 Save R102 (11%) Ships in 9 - 15 working days
Good Manufacturing Practices for Pharmaceuticals, Seventh Edition (Paperback, 7th edition): Graham P. Bunn Good Manufacturing Practices for Pharmaceuticals, Seventh Edition (Paperback, 7th edition)
Graham P. Bunn
R1,465 Discovery Miles 14 650 Ships in 12 - 17 working days

This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends. Key Features: Presents insight into the world of pharmaceutical quality systems Analyzes regulatory trends and expectations Includes approaches and practices used in the industry to comply with regulatory requirements Discusses recent worldwide supply chain issues Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry

Understanding Drugs Markets - An Analysis of Medicines, Regulations and Pharmaceutical Systems in the Global South (Hardcover):... Understanding Drugs Markets - An Analysis of Medicines, Regulations and Pharmaceutical Systems in the Global South (Hardcover)
Carine Baxerres, Maurice Cassier
R3,931 Discovery Miles 39 310 Ships in 12 - 17 working days

Drawing on anthropology, historical sociology and social-epidemiology, this multidisciplinary book investigates how pharmaceuticals are produced, distributed, prescribed, (and) consumed, and regulated in order to construct a comprehensive understanding of the issues that drive (medicine) pharmaceutical markets in the Global South today. Based on primary research conducted in Benin and Ghana, and additional data collected in Cambodia and the Ivory Coast, this volume uses artemisinin-based combination therapies (ACTs) against malaria as a central case study. It highlights the influence of the countries colonial and post-colonial history on their models for state regulation, production, and distribution, explores the determining role transnational actors as well as industries from the North but also and increasingly from the South play in influencing local pharmaceutical markets and looks at the behaviour of health care professionals and individuals. Stepping back, the authors then unpick the pharmaceuticalization process and the multiple regulations at stake by looking at the workings of, and linkages between, (biomedical health) pharmaceutical systems, (representatives of companies) industries, actors in private distribution, and consumer practices. Providing a thorough comparative analysis of the advantages and disadvantages of different pharmaceutical systems, it is an important contribution to the literature on pharmaceutalization and the governance of medication. It is of interest to students, researchers and policy-makers interested in medical anthropology, the sociology of health and illness, global health, healthcare management and pharmacy. The Open Access version of this book, available at http://www.taylorfrancis.com/books/9780429329517, has been made available under a Creative Commons Attribution-Non Commercial-No Derivatives 4.0 license.

Imitation to Innovation in China - The Role of Patents in Biotechnology and Pharmaceutical Industries (Hardcover): Yahong Li Imitation to Innovation in China - The Role of Patents in Biotechnology and Pharmaceutical Industries (Hardcover)
Yahong Li
R2,844 Discovery Miles 28 440 Ships in 12 - 17 working days

This volume fills an important need for understanding about the interplay between China's intellectual property protection system and the potential for innovation in China's economy. Using examples from the pharmaceutical and biotech industries, the author suggests that, despite the widely documented challenges facing China's IPR protection system, the system has a demonstrable effect on innovation. The author suggests that China's patent system promotes innovation through economic incentives, soft factors of public encouragement, and intentional development strategies. This book is also useful as an overview of China's biotech and pharmaceutical sectors, offering a range of richly detailed case studies on China's industrial development strategies in these sectors. A number of important patent disputes between Chinese and foreign companies are also examined to useful effect. In the highly contentious policy world of intellectual property protection and pharmaceutical and biotech industry development, the volume offers a refreshing combination of detail and insight.'uPitman B. Potter, University of British Columbia, Canada'Yahong Li's pioneering study, Imitation to Innovation in China, breaks new ground in closely examining the extent to which the Chinese government's patent policies and patent activity by Chinese firms are influencing China's coming transformation from an imitation-oriented country to an innovation-oriented one. Her combination of theoretical and empirical approaches exploring the links between public policy, patenting activity and technological innovation (commercialization) is an important contribution to development studies, not just for China but for other newly innovative countries as well.'uWilliam O. Hennessey, Franklin Pierce Law Center, USA Following decades in which China's approach to technology has been to imitate, the country is now transforming itself to become innovation-oriented. This pioneering study examines whether patents play as similar a role in promoting innovation in China as they do in the West, exploring the interplay between patents and China's biotechnology and pharmaceutical industries in particular. The author argues for a stronger patent regime based on an extensive review of the technological capacity, R&D models, patent filings and litigations, and issues in patent law, which involve China's biotechnology and pharmaceutical industries. By comparing China with other developing countries and analyzing China's uniqueness in terms of its development stage, technological capacity and the strengths and weaknesses in its patent system, the author concludes that China is distinguished from the prevailing view that patents play a limited role in innovation in developing countries. The book also discusses whether and how patents can promote innovation in China's biotechnology and pharmaceutical industries, based on the study of market scale, R&D capacity, innovation model and patent legislation and cases.

Freeze Drying of Pharmaceutical Products (Paperback): Davide Fissore, Roberto Pisano, Antonello Barresi Freeze Drying of Pharmaceutical Products (Paperback)
Davide Fissore, Roberto Pisano, Antonello Barresi
R1,411 Discovery Miles 14 110 Ships in 12 - 17 working days

Freeze Drying of Pharmaceutical Products provides an overview of the most recent and cutting-edge developments and technologies in the field, focusing on formulation developments and process monitoring and considering new technologies for process development. This book contains case studies from freeze dryer manufacturers and pharmaceutical companies for readers in industry and academia. It was contributed to by lyophilization experts to create a detailed analysis of the subject matter, organically presenting recent advancements in freeze-drying research and technology. It discusses formulation design, process optimization and control, new PAT-monitoring tools, multivariate image analysis, process scale-down and development using small-scale freeze-dryers, use of CFD for equipment design, and development of continuous processes. This book is for industry professionals, including chemical engineers and pharmaceutical scientists.

Intellectual Property Law and Access to Medicines - TRIPS Agreement, Health, and Pharmaceuticals (Hardcover): Srividhya... Intellectual Property Law and Access to Medicines - TRIPS Agreement, Health, and Pharmaceuticals (Hardcover)
Srividhya Ragavan, Amaka Vanni
R5,279 Discovery Miles 52 790 Ships in 12 - 17 working days

The history of patent harmonization is a story of dynamic actors, whose interactions with established structures shaped the patent regime. From the inception of the trade regime to include intellectual property (IP) rights to the present, this book documents the role of different sets of actors - states, transnational business corporations, or civil society groups - and their influence on the structures - such as national and international agreements, organizations, and private entities - that have caused changes to healthcare and access to medication. Presenting the debates over patents, trade, and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as it galvanized non-state and nonbusiness actors, the book highlights how an alternative framing and understanding of pharmaceutical patent rights emerged: as a public issue, instead of a trade or IP issue. The book thus offers an important analysis of the legal and political dynamics through which the contest for access to lifesaving medication has been, and will continue to be, fought. In addition to academics working in the areas of international law, development, and public health, this book will also be of interest to policy makers, state actors, and others with relevant concerns working in nongovernmental and international organizations.

Sterile Manufacturing - Regulations, Processes, and Guidelines (Hardcover): Sam A. Hout Sterile Manufacturing - Regulations, Processes, and Guidelines (Hardcover)
Sam A. Hout
R2,340 Discovery Miles 23 400 Ships in 12 - 17 working days

This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements. It covers regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH, emphasizing good manufacturing practice and inspection requirements in the manufacturing of medicinal products. Additionally, this book provides the fundamentals of aseptic techniques, quality by design, risk assessment, and management in support of sterile operations applications. It creates a link to the implementation of business practices in drug manufacturing and healthcare and forms a correlation between design strategies including a step-by-step process to ensure reliability, safety, and efficacy of healthcare products for human and animal use. The book also provides a connection between drug production and regulated applications by offering a review of the basic elements of sterile processing, and how to remain viable with solid strategic planning. The book is a concise reference for professionals and learners in the field of sterile operations that governs primarily, pharmaceutical and medical device space, but can also extend to food and cosmetics that require clean (aseptic) manufacturing applications. It also helps compounding pharmacists and GMP inspectors and auditors.

The Commercial use of Biodiversity - Access to Genetic Resources and Benefit-Sharing (Paperback): Kerry Ten Kate, Sarah A. Laird The Commercial use of Biodiversity - Access to Genetic Resources and Benefit-Sharing (Paperback)
Kerry Ten Kate, Sarah A. Laird
R1,090 Discovery Miles 10 900 Ships in 12 - 17 working days

Originally published in 1999 The Commercial Use of Biodiversity examines how biodiversity and the genetic material it contains are now as valuable resources. Access to genetic resources and their commercial development involve a wide range of parties such as conservation and research institutes, local communities, government agencies and companies. Equitable partnerships are not only crucial to conservation and economic development but are also in the interests of business and often required by law. In this authoritative and comprehensive volume, the authors explain the provisions of the Convention on Biological Diversity on access and benefit-sharing, the effect of national laws to implement these, and aspects of typical contracts for the transfer of materials. They provide a unique sector-by-sector analysis of how genetic resources are used, the scientific, technological and regulatory trends and the different markets in Pharmaceuticals, Botanical Medicines, Crop Development, Horticulture, Crop Protection, Biotechnology (in fields other than healthcare and agriculture) and Personal Care and Cosmetics Products. This will be an essential sourcebook for all those in the commercial chain, from raw material collection to product discovery, development and marketing, for governments and policy-makers drafting laws on access and for all the institutions, communities and individuals involved in the conservation, use, study and commercialisation of genetic resources.

Natural Products Pharmacology and Phytochemicals for Health Care - Methods and Principles in Medicinal Chemistry (Hardcover):... Natural Products Pharmacology and Phytochemicals for Health Care - Methods and Principles in Medicinal Chemistry (Hardcover)
A.K. Haghi, Debarshi Kar Mahapatra, Cristobal Noe Aguilar
R4,161 Discovery Miles 41 610 Ships in 12 - 17 working days

Medicinal chemistry and pharmacology are closely associated fields, and the use of natural products for their medicinal properties is ever-growing. The study of drugs from natural products and their effects on the living body are explored in this volume. The book looks into the research, discovery, and characterization of chemicals that exhibit biological effects. Providing an informative compilation of research, valuable case studies, and reviews of existing literature in the area, the book focuses on the ethnobotanical uses of natural products and phytochemicals for health care, including applications for diabetes, ulcers, wound healing, chronic alcoholism, hemorrhoidal treatment, cancer mitigation, pain management, immunotherapy, and more.

Forecasting for the Pharmaceutical Industry - Models for New Product and In-Market Forecasting and How to Use Them (Paperback):... Forecasting for the Pharmaceutical Industry - Models for New Product and In-Market Forecasting and How to Use Them (Paperback)
Arthur G. Cook
R1,255 Discovery Miles 12 550 Ships in 12 - 17 working days

In virtually every decision, a pharmaceutical executive considers some type of forecast. This process of predicting the future is crucial to many aspects of the company - from next month's production schedule, to market estimates for drugs in the next decade. The pharmaceutical forecaster needs to strike a delicate balance between over-engineering the forecast - including rafts of data and complex 'black box' equations that few stakeholders understand and even fewer buy into - and an overly simplistic approach that relies too heavily on anecdotal information and opinion. Art Cook's highly pragmatic guide explains the basis of a successful balanced forecast for products in development as well as currently marketed products. The author explores the pharmaceutical forecasting process; the varied tools and methods for new product and in-market forecasting; how they can be used to communicate market dynamics to the various stakeholders; and the strengths and weaknesses of different forecast approaches. The text is liberally illustrated with tables, diagrams and examples. The final extended case study provides the reader with an opportunity to test out their knowledge. Forecasting for the Pharmaceutical Industry is a definitive guide for forecasters as well as the multitude of decision makers and executives who rely on forecasts in their decision making.

Empire of Pain - The Secret History of the Sackler Dynasty (Paperback): Patrick Radden Keefe Empire of Pain - The Secret History of the Sackler Dynasty (Paperback)
Patrick Radden Keefe
R446 R319 Discovery Miles 3 190 Save R127 (28%) Ships in 12 - 17 working days
Pharmaceutical Powder Compaction Technology (Paperback, 2nd edition): Metin Celik Pharmaceutical Powder Compaction Technology (Paperback, 2nd edition)
Metin Celik
R1,725 Discovery Miles 17 250 Ships in 12 - 17 working days

Compaction of powder constituents-both active ingredient and excipients-is examined to ensure consistent and reproducible disintegration and dispersion profiles. Revised to reflect modern pharmaceutical compacting techniques, this second edition of Pharmaceutical Powder Compaction Technology guides pharmaceutical engineers, formulation scientists, and product development and quality assurance personnel through the compaction formulation process and application. This unique reference covers: The physical structure of pharmaceutical compacts Bonding phenomena that occur during powder compaction Compression mechanisms of pharmaceutical particles Theories and basic principles of powder compaction New topics include: Compaction data analysis techniques The migration of powder constituents into commercial manufacture Instrumentation for compaction Compaction functionality testing, which is likely to become a USP requirement Design space for compaction Metrics required for scalability in tablet compression Interactive compaction and preformulation database for commonly used excipients

Herbal Product Development - Formulation and Applications (Paperback): Anil K. Sharma, Raj K. Keservani, Surya Prakash Gautam Herbal Product Development - Formulation and Applications (Paperback)
Anil K. Sharma, Raj K. Keservani, Surya Prakash Gautam
R2,548 Discovery Miles 25 480 Ships in 12 - 17 working days

This new volume, Herbal Product Development: Formulation and Applications, addresses some of the challenges that hinder the path of successful natural products from laboratory to market. Highly skilled, experienced, and renowned scientists and researchers from around the globe offer up-to-date information that describes characteristics of herbs and herbal products, applications, evaluation techniques, and more. There is also a section dedicated to alternative medicinal strategies for the treatment and cure of diverse diseases. Also considered, of course, is the efficacy and safety of herbal products, which are of major concern. This valuable volume will be an important addition to the library of those involved in herbal product development and testing, including researchers, scientists, academicians, industry professionals, and students in this area.

Dictionary of Pharmaceutical Dosage Forms (Paperback): Jeffrey T. Solate Dictionary of Pharmaceutical Dosage Forms (Paperback)
Jeffrey T. Solate
R1,404 Discovery Miles 14 040 Ships in 12 - 17 working days

The study of pharmaceutical dosage forms has many connections to biological and medical sciences including physiology, biochemistry, pharmacology, pharmacotherapy, therapeutics, pharmacodynamics, pharmacokinetics, and pharmacognosy. Dictionary of Pharmaceutical Dosage Forms is a collection of terms and definitions prepared to assist healthcare practitioners and students as a companion or reference resource when reading notes and completing routine care. It can also provide reference material for hospital and medical staff, consultants, nursing instructors, and pharmaceutical science students. This first edition classifies and organizes the forms in an easily readable format, so readers will find it a quick and simple reference. Features Collects terms and definitions to assist healthcare practitioners and students as a companion or reference resource when reading notes and completing routine care Focuses on product dosage forms and includes supplementary information, providing readers, particularly pharmacy and medical students and professionals, insights into choices of dosage forms made during drug product development Offers information on the indications, contraindications, side effects, and more, for a given drug Classifies and organizes the forms in a readable format, providing a quick and simple reference

The Global Pharmaceutical Industry - The Demise and the Path to Recovery (Hardcover): Daniel Hoffman, Allan Bowditch The Global Pharmaceutical Industry - The Demise and the Path to Recovery (Hardcover)
Daniel Hoffman, Allan Bowditch
R3,907 Discovery Miles 39 070 Ships in 12 - 17 working days

The pharmaceutical industry, long thought of as a recession-proof investment, now faces a day of reckoning. The reasons for this impending downfall are not hard to discern. The prices the industry charges for its prescription drugs have escalated at four to five times the cost-of-living increases during the past two decades and have reached a point where 30% of Americans must choose between filling a prescription, paying for housing, and buying food. This has brought about public pressure on governments around the world to control drug prices, yet the world's twenty largest pharma companies realized 80% of their growth as a result of exorbitant price hikes. Pharma currently enjoys its extraordinary profitability by exploiting the world's most vulnerable populations. Yet even their ability to increase prices in the face of falling demand does not satisfy their profit demands. The breadth and depth of pharma's marketing transgressions exceed those of any other industry and have now reached a point where authorities around the world have found it necessary to take legal action against its violations. Drastic change is needed if the pharmaceutical industry can equitably advance the health of the world's population and regain public esteem. This book illustrates the range and extent of pharma's violations and addresses the actions that should be implemented in order to make the drug industry a more constructive, less venal part of contemporary society. It will be of interest to researchers, academics, practitioners, and students with an interest in the pharmaceutical industry, healthcare management, regulation, and bioethics.

Case Studies in Bayesian Methods for Biopharmaceutical CMC (Hardcover): Paul Faya, Tony Pourmohamad Case Studies in Bayesian Methods for Biopharmaceutical CMC (Hardcover)
Paul Faya, Tony Pourmohamad
R4,081 Discovery Miles 40 810 Ships in 12 - 17 working days

The subject of this book is applied Bayesian methods for chemistry, manufacturing, and control (CMC) studies in the biopharmaceutical industry. The book has multiple authors from industry and academia, each contributing a case study (chapter). The collection of case studies covers a broad array of CMC topics, including stability analysis, analytical method development, specification setting, process development and optimization, process control, experimental design, dissolution testing, and comparability studies. The analysis of each case study includes a presentation of code and reproducible output. This book is written with an academic level aimed at practicing nonclinical biostatisticians, most of whom have graduate degrees in statistics. * First book of its kind focusing strictly on CMC Bayesian case studies * Case studies with code and output * Representation from several companies across the industry as well as academia * Authors are leading and well-known Bayesian statisticians in the CMC field * Accompanying website with code for reproducibility * Reflective of real-life industry applications/problems

EU Law of Competition and Trade in the Pharmaceutical Sector (Hardcover): Pablo Figueroa, Alejandro Guerrero EU Law of Competition and Trade in the Pharmaceutical Sector (Hardcover)
Pablo Figueroa, Alejandro Guerrero
R7,596 Discovery Miles 75 960 Ships in 12 - 17 working days

This book provides a systematic analysis of the law and practice of EU competition/antitrust law and trade regulation in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-profile competition enforcers, this work provides valuable insider knowledge on the application of competition law and policies to the pharmaceutical industry. Key features include: Extensive commentary on the legislation and the latest case law and administrative precedents in the pharmaceutical sector, at both EU and national level Coverage of various key developments including the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers In-depth analysis of topics commonly raised in the pharmaceutical sector including: pricing policies, IP life-cycle management, IP licensing and horizontal cooperation agreements Key economic and business perspectives to accompany legal analysis, providing the reader with a rounded view of the subject matter. This book will be a useful resource for lawyers and in-house counsel active in the pharmaceutical sector. The information and analysis provided will prepare readers to take on cases and drive the antitrust review of transactions and agreements within the industry. Researchers, economists and civil servants with an interest in competition law and trade regulation can also benefit from the practical insights provided therein.

Burroughs Wellcome and Company - Knowledge, Trust, Profit and the Transformation of the British Pharmaceutical Industry,... Burroughs Wellcome and Company - Knowledge, Trust, Profit and the Transformation of the British Pharmaceutical Industry, 1880-1940 (Hardcover, Illustrated Ed)
Roy Church, E.M. Tansey
R1,091 Discovery Miles 10 910 Ships in 12 - 17 working days

Rarely in modern British history has a medium-sized company exercised such a dominant influence on an individual industry as Burroughs Wellcome and Co. This book explores the history and development of the company, beginning in the latter part of the 19th century.

Supplies Management for Health Services (Hardcover): Stanley Hyman Supplies Management for Health Services (Hardcover)
Stanley Hyman
R3,040 Discovery Miles 30 400 Ships in 12 - 17 working days

First published in 1979, Supplies Management for Health Services looks at the characteristics and problems of hospital suppliers and examines the way in which the hospital and the National Health Service deal with supplies problems and relations with suppliers. Beginning with a description of the National Health Service and its supplies' organisations and the role of the Department of Health and Social Security in this field, the book then reports on the detailed studies made over two years of the supplies' problems of ten London area health authorities and ten London manufacturers of medical equipment. The NHS situation is then contrasted with the supplies' situation in three non-health organisations and with the health supplies situation in France and West Germany. The final part of the book analyses the information obtained, proposes a means of assessing supplies systems, and evaluates the NHS situation. This is followed by the realistic proposals for reform, advocating a system similar to that used in British defence services, based on a central procurement agency, close cooperation with private manufacturers, and manufacture by government where necessary. This book will surely interest students of economics and global health.

Microbial Contamination Control in the Pharmaceutical Industry (Paperback): Luis Jimenez Microbial Contamination Control in the Pharmaceutical Industry (Paperback)
Luis Jimenez
R1,867 Discovery Miles 18 670 Ships in 12 - 17 working days

This authoritative reference presents an up-to-date review of the testing methods, emerging technologies, and analytical systems and procedures used to prevent the microbial contamination of pharmaceutical processes, products, and environments. It identifies new tools for sample analysis and evaluation and the impact of these advancements on the continuous supply and manufacturing of pharmaceutical products. With more than 100 tables and 430 current references, the book contains a detailed analysis of microbial contamination recalls for nonsterile and sterile pharmaceutical products, demonstrating the distribution of microorganisms worldwide and the identification by geographical regions.

Dermatological and Transdermal Formulations (Paperback): Kenneth A. Walters Dermatological and Transdermal Formulations (Paperback)
Kenneth A. Walters
R1,905 Discovery Miles 19 050 Ships in 12 - 17 working days

Containing 350 illustrations, tables, and equations and covering AAPS/FDA guidelines for the experimentation and analysis of in vivo and in vitro percutaneous absorption, this reference provides comprehensive coverage of the development, preparation, and application of topical and transdermal therapeutic systems. Recognized international experts discuss the bioequivalence of dermatological and transdermal dosage forms. They explore the biochemistry and treatment of skin diseases, the structure and function of the skin, adverse dermal responses to drug formulations, mechanisms of drug transport through barrier membranes, and methods for measuring and modulating percutaneous permeation.

Particulate Interactions in Dry Powder Formulation for Inhalation (Paperback): Xian Ming Zeng, Gary Peter Martin, Christopher... Particulate Interactions in Dry Powder Formulation for Inhalation (Paperback)
Xian Ming Zeng, Gary Peter Martin, Christopher Marriott
R1,859 Discovery Miles 18 590 Ships in 12 - 17 working days

Interactions between drug particulates are crucial in determining drug dispersion and deaggregation, and ultimately delivery efficiency. This book combines principles and factors in pharmaceutical powder technology, critically reviews some of the studies carried out in dry powder formulation development, and proposes possible strategies for improving their efficiency. The majority of these principles are applicable to other pharmaceutical solid dosage forms (e.g. tablets and capsules).

Sterile Product Facility Design and Project Management (Paperback, 2nd edition): Jeffrey N. Odum Sterile Product Facility Design and Project Management (Paperback, 2nd edition)
Jeffrey N. Odum
R1,876 Discovery Miles 18 760 Ships in 12 - 17 working days

Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provides comprehensive guidance on how to develop and execute biotech and other sterile drug facilities based on current industry best practices. Each chapter highlights a specific issue centered on managing biotech facilities projects in a GMP environment. The author uses real-world examples of common industry practice to lead you through the idiosyncrasies of a biotech project in an effort to answer some of the more common, and often perplexing, questions that can stand in the way of success. You get a mini seminar on each topic covered. Breaking the project life-cycle into four phases, the text takes you through each phase from the Project Manager's viewpoint. Unlike other books that cover design, technology, and validation in general terms, this book addresses the industry specific issues that make biotech facilities so costly and difficult to deliver. It puts the pieces of the puzzle together in a manner that increases your opportunity for success.

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