This book is the definitive work on the theory and practice of pharmaceutical tablet and pellet coating. It describes both the practical and theoretical aspects of tablet coating, including the equipment and methods used in laboratory development, scale-up and production systems, More...as well as automation and validation. This book also discusses the problems of conforming to world-wide regulations, and the hazards of environmental pollution.

The pharmaceutical industry is under increasing pressure to do more with less. Drug discovery, development, and clinical trial costs remain high and are subject to rampant inflation. Ever greater regulatory compliance forces manufacturing costs to rise despite social demands for more affordable health care. Traditional methodologies are failing and the industry needs to find new and innovative approaches for everything it does. Six Sigma in the Pharmaceutical Industry: Understanding, Reducing, and Controlling Variation in Pharmaceuticals and Biologics is the first book to focus on the building blocks of understanding and reducing variation using the Six Sigma method as applied specifically to the pharmaceutical industry. It introduces the fundamentals of Six Sigma, examines control chart theory and practice, and explains the concept of variation management and reduction. Describing the approaches and techniques responsible for their own significant success, the authors provide more than just a set of tools, but the basis of a complete operating philosophy. Allowing other references to cover the structural elements of Six Sigma, this book focuses on core concepts and their implementation to improve the existing products and processes in the pharmaceutical industry. The first half of the book uses simple models and descriptions of practical experiments to lay out a conceptual framework for understanding variation, while the second half introduces control chart theory and practice. Using case studies and statistics, the book illustrates the concepts and explains their application to actual workplace improvements. Designed primarily for the pharmaceutical industry, Six Sigma in the Pharmaceutical Industry: Understanding, Reducing, and Controlling Variation in Pharmaceuticals and Biologics provides the fundamentals of variation management and reduction in sufficient detail to assist in transforming established methodologies into new and efficient techniques.

Vast global resources are ploughed into the delivery of treatment interventions ranging from diet and lifestyle advice to complex surgery. In all cases, whatever the intervention, unless the recipient is engaged with the process and understands why the intervention has been offered and the part they play in its success, compliance is an issue. Even where the individual does engage and understand, he or she may choose not to comply. Non-compliance is estimated to cost the pharma industry US$70 billion per year. No figures exist for the cost to healthcare insurers and public health but non-compliance is undoubtedly one of the top five issues facing both drug developers and healthcare providers. During clinical trials, non-compliance undermines the accuracy of the data generated from the whole trial as well as particular aspects such as the efficacy of different dosages. This book explores the key factors which drive compliance and the part that healthcare professionals can play in improving this, with the key underlying goal of improving public health in its broadest sense.

From Physick to Pharmacology addresses the important, albeit neglected history of the distribution and sale of medicinal drugs in England from the sixteenth to the twenty-first century. The social history of early medicine and the evolution of British retailing are two areas that have attracted considerable attention from academics in recent years. That said, little work has been done either by medical or business historians on the actual retailing of drugs. This book merges the two themes by examining the growth in the retailing of medicinal drugs since late-medieval times. The six academics contributing essays include both medical and business historians who provide an informed and stimulating perspective on the subject. After an introduction setting out the context of drug retailing and surveying the current literature, the volume is arranged in a broadly chronological order, beginning with Patrick Wallis's study of apothecaries and other medical retailers in early modern London. The next chapter, by Louise Hill Curth, looks at the way the distribution network expanded to encompass a range of other retail outlets to sell new, branded, pre-packaged proprietary drugs. Steven King then examines various other ways in which medicines were sold in the eighteenth century, with a focus on itinerant traders. This is followed by pieces from Hilary Marland on the rise of chemists and druggists in the nineteenth century, and Stuart Anderson on twentieth-century community pharmacists. The final essay, by Judy Slinn, examines the marketing and consumption of prescription drugs from the middle of that century until the present day. Taken together, these essays provide a fascinating insight into the changes and continuities of five centuries of drug retailing in England.

Melville's Monumental Imagination explores the connection between the contested 19th century American monument tradition and one of the nation's most revered authors, Herman Melville (1819-1891). The book was written to fill a void in recent Melville scholarship. To date, there has not been a monograph that focuses exclusively on Melville's incorporation of monuments in his fictional world. The book charts the territory of Melville's novels in order to provide a trajectory of the monumental image in one particular literary form. This feature allows the reader to gradually see the monumental image as an important marker that sheds light into Melville's eventual abandonment of long fiction. Melville's Monumental Imagination combines literary analysis and cultural criticism for a long neglected aspect of our nation's iconic development in statuary.

As business processes are crucial success factors for companies, software-based Business Process Management (BPM) is becoming more and more important. In this area SAP, the market leader for enterprise application software, has already gathered substantial experience. For the characterization, modeling and especially the optimization of business processes, SAP's consultants use their own BPM approach. In addition to their considerable methodological know-how, the consultants' profound knowledge of the industries facilitates the focus on core and business-critical processes. This book examines the current market situation, as well as the specific challenges and trends for the chemical and pharmaceutical industries. It also explains business process management basics and the specific SAP Consulting methodology, before illustrating the use of such methods and procedures with sample industry-specific core business processes. With the help of these examples from the chemical and pharmaceutical industries, SAP Consulting provides methodological guidelines on how Business Process Management can be used in practice to optimize business processes and make adjustments in response to constantly changing economic and environmental factors.

Israel's 2003 election took place against the background of a deteriorating security situation (due to Palestinian violence and the impending US War in Iraq) and severe disillusionment with the Oslo peace process. The election, which brought about a decisive victory of the Likud Party and Ariel Sharon, took place amidst strong accusations of corruption and the virtual collapse of the Israeli left. The election also featured the rise of the anti-clerical Shinui party, which resulted in the exclusion of the ultra-Orthodox parties from the new coalition. In this volume, leading Israeli political scientists explore the main actors and processes that shaped the election and its outcome.
This book was previously published as a special issue of the journal Israel Affairs.

When a problem arises with a product regulated by FDA, the Agency can take a number of actions to protect the public health. Initially, the agency works with the manufacturer to correct the problem voluntarily. If that fails, administrative enforcement and legal remedies include asking the manufacturer to recall a product and having federal marshals seize products if a voluntary recall is not done. Drugs can be seized and medical devices can be detained and imports can be stopped at the port of entry until problems are corrected. If warranted, FDA can ask the courts to issue injunctions or prosecute those that deliberately violate the law. When warranted, criminal penalties-including prison sentences-are sought. Ensuring that your company is in compliance at all times in all departments is a never-ending task. Failure to get it right, even once, can mean excessive fines, penalties, or possible debarment. The FDA Administrative Enforcement Manual explores the control of drug research in pharmaceutical, vaccine, biologic, biotechnology, medical device, and cosmeceutical industries. Introducing basic industry techniques, the author explores every day industry problems and presents suggested methods for applying the theory to resolve them. The book covers the ten critical Administrative Enforcement areas, including recalls, application integrity, injunctions, seizures, and more. It supplements these topics with regulations, lawsuit case studies, enforcement information, and reference materials. Offering insight into the impact of FDA enforcement on the national and international pharmaceutical industry, practitioners and industry suppliers, the book provides an understanding of drug development and manufacturing regulations in the United States and shows you what it takes to keep your company in compliance. The only complete, single source available, the FDA Administrative Enforcement Manual draws on the author's experience in the trenches of the pharmaceutical industry with administrative enforcement activities.

This title was first published in 2003. Presenting information is a vital part of the job of both the medical director and other senior executives in the pharmaceutical industry, and yet the majority receive no training for this. Presentations have to be made internally to colleagues, clinical staff, marketing and product managers and medical sales representatives; and externally to professional medical specialists and NHS staff, the media and the general public. Anyone who manages or communicates adverse news needs to do so quickly and effectively, and be prepared to face difficult questions under media scrutiny. In this book, John Lidstone, an author acknowledged by the industry as an expert in marketing and presentation skills, provides readers with the tools and skills to make their presentations and media dealings a success. The book is divided into two parts. Part One, Preparing and Delivering Formal Presentations, provides extensive practical guidance on the techniques of effective presenting: establishing objectives and preparing the presentation, delivering the opening, core and conclusion, using visual aids and dealing with questions. It also includes a chapter on the skills required for video conferencing. The second part, Handling the Media, contains invaluable insight and instruction for a pharmaceutical executive facing any element of the media. It draws on the author's extraordinary experience and provides examples and advice with direct relevance to the pharmaceutical industry throughout, making this the only specialist book available on the subject.

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.

Leads readers through the multitude of tasks involved in the control of microbiological contamination in the production of parenteral drugs. This reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and validation of new parenteral facilities; and the monitoring of clean environments vividly illustrating the routes by which products, processes, and manufacturing settings become contaminated through contact with the air, water, raw materials, and the actions of personnel, as well as the current methods necessary to successfully preclude contamination.

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.

This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on: * FDA regulations * EC and IPEC guidelines * ISO/BSI standards referenced in the checklists furnished in volume 1 Easy-to-read and organized to provide fast access to guidelines and regulations, this is an essential reference for those working in the field.

Lists the necessary steps for meeting compliance requirements during the drug development process. Presents comprehensive approaches for validating analytical methods for pharmaceutical applications. Features key discussions on pre-approval inspections.

The pharmaceutical industry has changed beyond all recognition in the past 100 years. The modern industry is constantly in the news as new breakthroughs in medical treatment are announced, often provoking ethical and social debates about the implications of new technologies. This volume facilitates the study of the industry by providing information on the present location of pharmaceutical archives. The core of the book consists of a business-by-business guide to the industry's records. Each entry includes a brief history of the company, a summary of its surviving archives and a bibliography of related publications. Similar entries exist for trade associations and schools of pharmacy associated with the industry and there are two appendices listing small collections of records held and relevant public records. The historical compendium is supplemented by three introductory essays, written by leading academics in the field, outlining the history of the industry and describing the nature and uses of the archival records which it has created. These essays are supplemented by a select chronology of pharmaceutical legislation and a select bibliography of histories relating to the pharmaceutical industry in general. A users guide helps readers understand how the business entries were constructed and is supplemented by a glossary of terms used in this book As such, this book will no doubt prove an invaluable resource to researchers undertaking comparative studies of the pharmaceutical industry, the history of medicine and the retailing of medical drugs.

Contents:
1. Introduction 2. The Pharmaceutical Development Process 3. The Medical Device Development Process 4. Functions and Types of CRO's (referencing function listings in appendices) 5. Selection of CRO 6. Pricing and Cost 7. Monitoring Work 8. Common Problems and their Solutions

Pharmaceutical Process Validation, Third Edition explores the roots of pharmaceutical process validation originating in Switzerland and Germany in the 1980s. It covers troubleshooting procedures, validation in contract manufacturing, and harmonization trends. New chapters include Validation for Medical Devices, Validation of Biotechnology Processes, Transdermal Process Validation, Integrated Packaging Validation, Statistical Methods for Uniformity and Dissolution Testing, Change Control and SUPAC, Validation in Contract Manufacturing, and Harmonization, GMPs, and Validation. It includes contributions by research and industry specialists from the U.S., Europe, and Japan.

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval. New chapters cover: the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance pharmacovigilance programs designed to prevent widespread safety issues legal issues surrounding the sourcing of foreign APIs the issues of counterfeit drugs updates on quality standards

The goal of an activity-directed isolation process is to isolate bioactive compounds which may provide structural leads of therapeutic importance. Whereas the traditional process of drug development is long and expensive, simple and rapid bioassays can serve as the starting point for drug discovery. This book presents a range of "bench top" bioassay techniques useful for natural product and pharmaceutical chemists involved in drug discovery and pharmacognosy. The contents detail a number of enzyme-based assays, cell-based functional bioassays and receptor radioligand binding assays along with detailed descriptions of each type. The majority of these bioassays are presented in a step-by-step format, so they could even be implemented by technical personnel with little background in microbiology, biochemistry or pharmacology.

Looks at the significant political and economic impact that the modern pharmaceutical industry has had on society taking an analytical approach to this high profile and controversial topic.
It explains how and why the modern pharmaceutical industry evolved and explores important topics such as drug promotion and regulation. It provides
* informative accessible and relevant information for both professionals and students from all backgrounds
* takes an analytical rather than a purely descriptive approach
The book will supply valuable information for all those who work in or with the pharmaceutical industry, health economists and health service researchers.

This Book explains and investigates how medicines are controlled in Europe, especially the EU. Based on penetrating documentary and interview research with the pharmaceutical industry, regulators and consumer organisations,it provides the first major critical examination of the new Europeanised systems of medicine regulation. The authors argue that the drive to produce and approve more drugs more quickly for a single European market dominates other considerations, such as improvements in democratic accountability, the independence of regulators and scientific expertise from commercial interests, and drug safety testing and surveillance.

This book answers the questions about the process and costs of pharmaceutical R & D in a compelling narrative focused on the discovery and development of important new medicines. It gives an insider's account of the pharmaceutical industry drug discovery process, the very real costs of misperceptions about the industry, the high stakes--both economic and scientific--of developing drugs, the triumphs that come when new compounds reach the market and save lives, and the despair that follows when new compounds fail. In the book, John LaMattina, former president of Pfizer Global Research and Development, weaves themes critical to a vital drug discovery environment in the context. This is a story that Dr. LaMattina is uniquely qualified to tell.

This invaluable reference presents a comprehensive review of the basic methods for characterizing bioadhesive materials and improving vehicle targeting and uptake-offering possibilities for reformulating existing compounds to create new pharmaceuticals at lower development costs.
Evaluates the unique carrier characteristics of bioadhesive polymers and their power to enhance localization of delivered agents, local bioavailability, and drug absorption and transport
Written by over 50 international experts and reflecting broad knowledge of both traditional bioadhesive strategies and novel clinical applications, Bioadhesive Drug Delivery Systems
discusses mechanical and chemical bonding, polymer-mucus interactions, the effect of surface energy in bioadhesion, polymer hydration, and mucus rheology
analyzes biochemical properties of mucus and glycoproteins, cell adhesion molecules, and cellular interaction with two- and three-dimensional surfaces
covers microbalances and magnetic force transducers, atomic force microscopy, direct measurements of molecular level adhesions, and methods to measure cell-cell interactions
examines bioadhesive carriers, diffusion or penetration enhancers, and lectin-targeted vehicles
describes vaginal, nasal, buccal, ocular, and transdermal drug delivery
reviews bioadhesive interactions with the mucosal tissues of the eye and mouth, and those in the respiratory, urinary, and gastrointestinal tracts
explores issues of product development, clinical testing, and production
and more
Amply referenced with over 1400 bibliographic citations, and illustrated with more than 300 drawings, photographs, tables, and display equations, Bioadhesive Drug Delivery Systems serves as a sound basis for innovation in bioadhesive systems and an excellent introduction to the subject. This unique reference is ideal for pharmaceutical scientists and technologists; chemical, polymer, and plastics engineers; biochemists; physical, surface, and colloid chemists; biologists; and upper-level undergraduate and graduate students in these disciplines.

This work considers the concepts and constraints that have to be considered in the design of small, medium and large scale production plants. The layout, along with the flow of materials and personnel through facilities are considered with reference to ensuring compliance with current good manufacturing practice. The book explains how clean rooms have developed, and how recent regulations affect their design. The latest concepts for reducing contamination levels from the operator and the product are discussed. It assess current changes in standards and quality control and makes suggestions for the "ideal production environment" to enable standards to be validated to current standards.

eBook available with sample pages: 0203483111

This title was first published in 2003. Presenting information is a vital part of the job of both the medical director and other senior executives in the pharmaceutical industry, and yet the majority receive no training for this. Presentations have to be made internally to colleagues, clinical staff, marketing and product managers and medical sales representatives; and externally to professional medical specialists and NHS staff, the media and the general public. Anyone who manages or communicates adverse news needs to do so quickly and effectively, and be prepared to face difficult questions under media scrutiny. In this book, John Lidstone, an author acknowledged by the industry as an expert in marketing and presentation skills, provides readers with the tools and skills to make their presentations and media dealings a success. The book is divided into two parts. Part One, Preparing and Delivering Formal Presentations, provides extensive practical guidance on the techniques of effective presenting: establishing objectives and preparing the presentation, delivering the opening, core and conclusion, using visual aids and dealing with questions. It also includes a chapter on the skills required for video conferencing. The second part, Handling the Media, contains invaluable insight and instruction for a pharmaceutical executive facing any element of the media. It draws on the author's extraordinary experience and provides examples and advice with direct relevance to the pharmaceutical industry throughout, making this the only specialist book available on the subject.