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Controlling Pharmaceutical Risks

Author : John Abraham
ISBN : 0415622476
Genre : Medical
File Size : 63. 1 MB
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Controlling Pharmaceutical Risks is a case study of changes in drug testing since the late 1990s, specifically geneticization of carcinogenic risk assessment and regulation of pharmaceuticals. Radically new ways of determining whether medical drugs might cause cancer have been established world-wide since the turn of the century. At the heart of these transformations is the geneticization of drug testing and explanations for cancer induction. The most dramatic change in toxicology for over 30 years, geneticization is poised to revolutionize this life science by abolishing long-term animal testing. This situation has come about by a combination of technical and socio-political transmutations. At stake are issues fundamental to bio-science, medical treatment and patients' health in wider society, such as what kind of knowledge is judged necessary to decide whether or not a drug is a carcinogen and when does a drug pose a significant carcinogenic risk to humans? Given that all new drugs, many with prospective world-wide markets, are potential carcinogens, this is an extremely important socio-political issue, but has been largely neglected in social science and indeed medicine. This is the first social science/policy book on the geneticization of international pharmaceutical testing and pharmaceutical toxicology. The book challenges the idea that the geneticization of carcinogenic risk assessment is simply a reflection of inevitable progress in laboratory science. Rather, a basic contention of this book is that such developments are framed and constituted by discursive and non-discursive practices, involving confluence of technical manipulations and socio-political accomplishments. The in-depth empirical research forms the basis for explaining the social shaping of carcinogenic risk assessment, the social meaning of its geneticization and the public health implications of the consequent 'reduction' in this regulatory science for society.

Pharmaceutical Rd Costs Risks And Rewards

Author :
ISBN : 9781428921030
Genre :
File Size : 74. 24 MB
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Biocontamination Control For Pharmaceuticals And Healthcare

Author : Tim Sandle
ISBN : 9780128149126
Genre : Medical
File Size : 21. 60 MB
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Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. This key part of controlling risk escalation can lead to the contamination of medicinal products, hence necessary tracking precautions are essential. Regulatory authorities have challenged pharmaceutical companies, healthcare providers, and those in manufacturing practice to adopt a holistic approach to contamination control. New technologies are needed to introduce barriers between personnel and the environment, and to provide a rapid and more accurate assessment of risk. This book offers guidance on building a complete biocontamination strategy. Provides the information necessary for a facility to build a complete biocontamination strategy Helps facilities understand the main biocontamination risks to medicinal products Assists the reader in navigating regulatory requirements Provides insight into developing an environmental monitoring program Covers the types of rapid microbiological monitoring methods now available, as well as current legislation

Oral Controlled Release Formulation Design And Drug Delivery

Author : Hong Wen
ISBN : 1118060326
Genre : Science
File Size : 42. 92 MB
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This book describes the theories, applications, and challenges for different oral controlled release formulations. This book differs from most in its focus on oral controlled release formulation design and process development. It also covers the related areas like preformulation, biopharmaceutics, in vitro-in vivo correlations (IVIVC), quality by design (QbD), and regulatory issues.

Drug Benefits And Risks

Author : Christoffel Jos van Boxtel
ISBN : 9781586038809
Genre : Medical
File Size : 87. 79 MB
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Explores the scientific basis and practice of drug therapy. This book examines the practice of clinical pharmacology and pharmacotherapy in the developing as well as the developed world. It covers general clinical pharmacology, pharmacology of various drug groups and the treatments specific to various diseases.

Urban Water Security Managing Risks

Author : Blanca Jimenez Cisneros
ISBN : 9781134011933
Genre : Science
File Size : 70. 29 MB
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Understanding the impacts of urbanization on the urban water cycle and managing the associated health risks demand adequate strategies and measures. Health risks associated with urban water systems and services include the microbiological and chemical contamination of urban waters and outbreak of water-borne diseases, mainly due to poor water and s

Risk Management Applications In Pharmaceutical And Biopharmaceutical Manufacturing

Author : Hamid Mollah
ISBN : 9781118514344
Genre : Science
File Size : 31. 43 MB
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Sets forth tested and proven risk management practices indrug manufacturing Risk management is essential for safe and efficientpharmaceutical and biopharmaceutical manufacturing, control, anddistribution. With this book as their guide, readers involved inall facets of drug manufacturing have a single, expertly written,and organized resource to guide them through all facets of riskmanagement and analysis. It sets forth a solid foundation in riskmanagement concepts and then explains how these concepts areapplied to drug manufacturing. Risk Management Applications in Pharmaceutical andBiopharmaceutical Manufacturing features contributions fromleading international experts in risk management and drugmanufacturing. These contributions reflect the latest research,practices, and industry standards as well as the authors' firsthandexperience. Readers can turn to the book for: Basic foundation of risk management principles, practices, andapplications Tested and proven tools and methods for managing risk inpharmaceutical and biopharmaceutical product manufacturingprocesses Recent FDA guidelines, EU regulations, and internationalstandards governing the application of risk management to drugmanufacturing Case studies and detailed examples demonstrating the use andresults of applying risk management principles to drug productmanufacturing Bibliography and extensive references leading to the literatureand helpful resources in the field With its unique focus on the application of risk management tobiopharmaceutical and pharmaceutical manufacturing, this book is anessential resource for pharmaceutical and process engineers as wellas safety and compliance professionals involved in drugmanufacturing.

Microbiological Contamination Control In Pharmaceutical Clean Rooms

Author : Nigel Halls
ISBN : 1420025805
Genre : Medical
File Size : 23. 10 MB
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Contamination control in pharmaceutical clean rooms has developed from a jumble of science and engineering, knowledge of what has worked well or badly in the past, dependent upon the technology available at the time the clean room was built and subsequent technological developments. Surrounding it all is a blanket of regulations. Taking a multidisc

Pharmaceutical Computer Systems Validation

Author : Guy Wingate
ISBN : 9781420088953
Genre : Medical
File Size : 55. 57 MB
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Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews r

Managed Care Pharmacy Practice

Author : Robert Navarro
ISBN : 0834212056
Genre : Health & Fitness
File Size : 79. 18 MB
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Written from a practical perspective, Managed Care Pharmacy Practice takes the reader through the issues critical to development and operation of a managed care pharmacy program. The reader will gain new insights into how managed care has altered the delivery of pharmacy services, as well as into the evolving role of pharmacists.Managed Care Pharmacy Practice explains the fundamentals of developing and operating a successful managed care pharmacy benefit, and also supplies insightful guidance on professional careers in the field. This text takes a sequential approach to history, background, program components, program development, operations, and performance measurement, with 25 chapters arranged in three main sections.

Hospital Pharmacy

Author : Martin Stephens
ISBN : 0853695024
Genre : Medical
File Size : 26. 77 MB
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The pharmacy department is now an established part of most hospitals with the pharmacist playing a pivotal role in the pharmaceutical care of the patient. Hospital Pharmacy recognises the changes in the practice of pharmacy within the hospital setting and provides a detailed discussion of the vast range of services that are now provided. Each chapter is devoted to an area of pharmacy practice and considers its history and current practice before concluding with future developments. As well as considering well-established facets of hospital pharmacy practice, such as technical services and clinical pharmacy, this text also considers the evolving relationship of the hospital pharmacy with other healthcare departments.

Encyclopaedia Of Occupational Health And Safety

Author : Jeanne Mager Stellman
ISBN : 9221098168
Genre : Electronic books
File Size : 54. 55 MB
Format : PDF
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Risk Assessment And Risk Management In The Pharmaceutical Industry

Author : James L. Vesper
ISBN : UOM:39015064768164
Genre : Business & Economics
File Size : 77. 91 MB
Format : PDF
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Risk Sharing In The Pharmaceutical Industry

Author : Gerrit Reepmeyer
ISBN : 3790816671
Genre : Business & Economics
File Size : 43. 86 MB
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The productivity in pharmaceutical research and development faces intense pres sure. R&D expenditures of the major US and European companies have topped US$ 33 billion in 2003 compared to around US$ 13 billion just a decade ago. At the same time, the number of new drug approvals has dropped from 53 in 1996 to only 35 in 2003. Moreover, the protraction of clinical trials has significantly reduced the effective time of patent protection. The consequences are devastating. Monopoly profits have started to decline and the average costs per new drug have reached a re cord level of close to US$ 1 billion today. As a result, any failure of a new sub stance in the R&D process can lead to considerable losses, and the risks of introduc ing a new drug to the market have grown tremendously. Particularly if a company is highly dependent on just a handful of mega-selling blockbuster drugs, the risks can be even greater. For example, Pfizer generated about 90% of its worldwide revenues in 2002 with just 8 products. Any shortfall of a promising late-stage drug candidate would have left Pfizer with a gaping hole in its product portfolio. In order to deal with these risks, many pharmaceutical companies have started to organize their R&D in partnership. In fact, more than 600 alliances in pharmaceutical R&D are signed every year.

Simple Tools And Techniques For Enterprise Risk Management

Author : Robert J. Chapman
ISBN : 9781119990642
Genre : Business & Economics
File Size : 60. 16 MB
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Your business reputation can take years to build—and mere minutes to destroy The range of business threats is evolving rapidly but your organization can thrive and gain a competitive advantage with your business vision for enterprise risk management. Trends affecting markets—events in the global financial markets, changing technologies, environmental priorities, dependency on intellectual property—all underline how important it is to keep up to speed on the latest financial risk management practices and procedures. This popular book on enterprise risk management has been expanded and updated to include new themes and current trends for today's risk practitioner. It features up-to-date materials on new threats, lessons from the recent financial crisis, and how businesses need to protect themselves in terms of business interruption, security, project and reputational risk management. Project risk management is now a mature discipline with an international standard for its implementation. This book reinforces that project risk management needs to be systematic, but also that it must be embedded to become part of an organization's DNA. This book promotes techniques that will help you implement a methodical and broad approach to risk management. The author is a well-known expert and boasts a wealth of experience in project and enterprise risk management Easy-to-navigate structure breaks down the risk management process into stages to aid implementation Examines the external influences that bring sources of business risk that are beyond your control Provides a handy chapter with tips for commissioning consultants for business risk management services It is a business imperative to have a clear vision for risk management. Simple Tools and Techniques for Enterprise Risk Management, Second Edition shows you the way.

Quality Risk Management In The Fda Regulated Industry

Author : José Rodríguez Pérez
ISBN : 9780873898348
Genre : Business & Economics
File Size : 30. 93 MB
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Risk management principles are effectively utilized in many areas of business and government, including finance, insurance, occupational safety, and public health, and by agencies regulating these industries. The U.S. Food and Drug Administration (FDA) and its worldwide counterparts are responsible for protecting public health by ensuring the safety and effectiveness of the drugs and medical devices. Regulators must decide whether the benefits of a specific product for patients and users outweigh its risk, while recognizing that “absolute safety” (or zero risk) is not achievable. Every product and every process has an associated risk. Although there are some examples of the use of quality risk management in the FDA-regulated industry today, they are limited and do not represent the full contribution that risk management has to offer. The present FDA focus on risk-based determination is requiring that the regulated industries improve dramatically their understanding and capability of hazard control concepts. In addition, the importance of quality systems has been recognized in the life sciences industry, and it is becoming evident that quality risk management is a valuable component of an effective quality system. The purpose of this book is to offer a systematic and very comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practices or good laboratory practices. The content of this book will provide FDA-regulated manufacturers with a framework within which experience, insight, and judgment are applied systematically to manage the risks associated with their products. Manufacturers in other industries may use it as an informative guidance in developing and maintaining a risk management system and process. The two appendices add even more insight: Appendix A contains general examples of risk management, while Appendix B includes 10 case studies illustrating real examples of the quality risk management process across the medical product arena.

Pharmaceutical Practice International Edition E Book

Author : Arthur J. Winfield
ISBN : 9780702041877
Genre : Medical
File Size : 53. 13 MB
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This comprehensive book covers a wide range of subjects relevant to pharmacy practice, including communication skills, managing a business, quality assurance, dispensing, calculations, packaging, storage and labeling of medicines, sterilization, prescriptions, hospital-based services, techniques and treatments, adverse drug reactions, pharmacoeconomics, and medicines management. Features useful appendices on medical abbreviations, pharmaceutical Latin terms, weights and measures, and presentation skills. This is a core text for pharmacy practice and dispensing modules of the pharmacy curriculum Covers key exam material for essential review and test preparation Features a user-friendly design with clear headings, chapter summaries, helpful boxes, and key points Text restructured with 14 new or radically revised chapters. All text revised in light of current pharmaceutical practice. New design using two colours.

Pharmaceutical Stress Testing

Author : Steven W. Baertschi
ISBN : 9781439801802
Genre : Medical
File Size : 76. 79 MB
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The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability into the physical aspects of stress testing, and incorporates the concept of Quality by Design into the stress testing construct / framework. It has been revised and expanded to include chapters on large molecules, such as proteins and antibodies, and it outlines the changes in stress testing that have emerged in recent years. Key features include: A renowned Editorial team and contributions from all major drug companies, reflecting a wealth of experience. 10 new chapters, including Stress Testing and its relationship to the assessment of potential genotoxic degradants, combination drug therapies, proteins, oligonucleotides, physical changes and alternative dosage forms such as liposomal formulations Updated methodologies for predicting drug stability and degradation pathways Best practice models to follow An expanded Frequently Asked Questions section This is an essential reference book for Pharmaceutical Scientists and those working in Quality Assurance and Drug Development (analytical sciences, formulations, chemical process, project management).

A Strategy For Assessing And Managing Occupational Exposures

Author : William H. Bullock
ISBN : 9781931504690
Genre : Business & Economics
File Size : 29. 45 MB
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Leachables And Extractables Handbook

Author : Douglas J. Ball
ISBN : 9781118147689
Genre : Science
File Size : 60. 62 MB
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A practical and science-based approach for addressingtoxicological concerns related to leachables and extractablesassociated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal DrugProducts (OINDP)—such as metered dose inhalers, dry powderinhalers, and nasal sprays—pose potential safety risks fromleachables and extractables, chemicals that can be released ormigrate from these components into the drug product. Addressing theconcepts, background, historical use, and development of safetythresholds and their utility for qualifying leachables andextractables in OINDP, the Leachables and Extractables Handbooktakes a practical approach to familiarize readers with the recentrecommendations for safety and risk assessment established througha joint effort of scientists from the FDA, academia, and industry.Coverage includes best practices for the chemical evaluation andmanagement of leachables and extractables throughout thepharmaceutical product life cycle, as well as: Guidance for pharmaceutical professionals to qualify andrisk-assess container closure system leachables and extractables indrug products Principles for defining toxicological safety thresholds that areapplicable to OINDP and potentially applicable to other drugproducts Regulatory perspectives, along with an appendix of key terms anddefinitions, case studies, and sample protocols Analytical chemists, packaging and device engineers, formulationdevelopment scientists, component suppliers, regulatory affairsspecialists, and toxicologists will all benefit from the wealth ofinformation offered in this important text.

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