Bad Pharma


Book Description

Originally published in 2012, revised edition published in 2013, by Fourth Estate, Great Britain; Published in the United States in 2012, revised edition also, by Faber and Faber, Inc.




Careers with the Pharmaceutical Industry


Book Description

In recent years, many factors have combined to change the operating environment of the international pharmaceutical industry leading to greater specialisation and sophistication. This new edition will give an update of the different opportunities in drug discovery and development and the scientific, medical or other specialist training needed to accomplish them. The scope of this edition has been broadened to encompass all major roles, including marketing and sales.




Express Series English for the Pharmaceutical Industry


Book Description

Please note that the Print Replica PDF digital version does not contain the audio. English for the Pharmaceutical Industry is part of the EXPRESS SERIES. It is the ideal quick course for anyone who needs English to communicate with colleagues and contacts in the pharmaceutical sector. It can be used to supplement a regular coursebook, on its own, as a stand-alone intensive specialist course, or for self-study. Whichever part of the industry you work in – Research, Development, Manufacturing, or Marketing – English for the Pharmaceutical Industry will give you the English you need to communicate across this complex sector.




An Introduction to Pharmaceutical Sciences


Book Description

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. - Unified approach explaining drug discovery, bulk drug manufacturing, formulation of dosage forms, with pharmacological and therapeutic actions - Manufacturing processes of representative active pharmaceutical ingredients and their chemistry plus formulation of dosage forms presented in this book are based on actual industrial processes - Covers many aspects relevant to students of the pharmaceutical sciences or newly employed pharmaceutical researchers/employees. It contains summary information about regulatory agencies of different countries




Big Pharma


Book Description

Pharmaceutical medicine is very, very big business. The top ten players earned more than $200 billion in 2003. One drug, Pfizer's cholesterol pill Lipitor, had sales of more than $9 billion. This kind of money buys an awful lot of friends among doctors and politicians. Most of those involved in the formulation of public health policy seems happy with the present system. The trouble is that the public is starting to have doubts. There is a growing sense that the vast profits of drug companies and their control of the research agenda might not be that good for our health. Jacky Law takes the reader on a journey through the pharmaceutical business and shows how the public is quite right to be concerned about conventional medicine, as it has developed since the late 1970s. She tells a story of spectacular regulatory failure, phenomenally high prices, betrayal of the public interest and a growing awareness among ordinary people that things could be very different. Sophisticated marketing and public relations, not scientific excellence, have helped corporations to preside unchallenged over matters of life and death. It is time, Law argues, for us to take responsibility for our health, not as passive consumers of pharmaceutical medicine, but as informed citizens.




Global Supply Chains in the Pharmaceutical Industry


Book Description

In a rapidly growing global economy, where there is a constant emergence of new business models and dynamic changes to the business ecosystem, there is a need for the integration of traditional, new, and hybrid concepts in the complex structure of supply chain management. Within the fast-paced pharmaceutical industry, product strategy, life cycles, and distribution must maintain the highest level of agility. Therefore, organizations need strong supply chain capabilities to profitably compete in the marketplace. Global Supply Chains in the Pharmaceutical Industry provides innovative insights into the efforts needed to build and maintain a strong supply chain network in order to achieve efficient fulfillment of demand, drive outstanding customer value, enhance organizational responsiveness, and build network resiliency. This publication is designed for supply chain managers, policymakers, researchers, academicians, and students, and covers topics centered on economic cycles, sustainable development, and new forces in the global economy.




Regulatory Affairs in the Pharmaceutical Industry


Book Description

Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance




Multivariate Analysis in the Pharmaceutical Industry


Book Description

Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each step. It includes an overview of regulatory guidance specific to the use of these methods, along with perspectives on the applications of these methods that allow for testing, monitoring and controlling products and processes. The book seeks to put multivariate analysis into a pharmaceutical context for the benefit of pharmaceutical practitioners, potential practitioners, managers and regulators. Users will find a resources that addresses an unmet need on how pharmaceutical industry professionals can extract value from data that is routinely collected on products and processes, especially as these techniques become more widely used, and ultimately, expected by regulators. - Targets pharmaceutical industry practitioners and regulatory staff by addressing industry specific challenges - Includes case studies from different pharmaceutical companies and across product lifecycle of to introduce readers to the breadth of applications - Contains information on the current regulatory framework which will shape how multivariate analysis (MVA) is used in years to come




English for the Pharmaceutical Industry


Book Description

English for the Pharmaceutical Industry teaches students how to communicate effectively in different areas of pharmaceuticals. The course is suitable for a range of pharmaceutical professionals, such as chemists, formulation scientists, lab technicians, medical writers, and clinical researchers. English for the Pharmaceutical Industry has six units which cover the core areas of pharmaceuticals, from initial substance discovery to the final stages of production and packaging. Every unit uses authentic situations and dialogues to concentrate on one fundamental aspect of the industry. This short, intensive course can be completed in 25-30 hours, so students make progress quickly. Table of contents: * Unit 1: The kick-off meeting: Providing information, introducing oneself, one's field and projects, summarizing action points, writing job ads. * Unit 2: Substance discovery: Asking about drug discovery and drug development, talking about time periods, asking for and giving opinions. * Unit 3: Quality assurance and auditing: Informing, asking questions during an audit, suggesting corrective action, discussing SOPs. * Unit 4: Reading for testing in live organisms: Describing a process, getting information, making suggestions, linking ideas, requesting information and responding directly. * Unit 5: Drug safety and regulatory affairs: Reporting severe adverse events, discussing the causes of SAEs, asking about implications form a drug, giving general advice, giving strong warnings. * Unit 6: Production and packaging: Expressing moments in time, giving instructions, describing a process, giving presentations.