Non-linear phenomena pervade the pharmaceutical sciences. Understanding the interface between each of these phenomena and the way in which they contribute to overarching processes such as pharmaceutical product development may ultimately result in more efficient, less costly and rapid implementation. The benefit to Society is self-evident in that affordable treatments would be rapidly forthcoming. We have aggregated these phenomena into one topic "Pharmaco-complexity: Non-linear Phenomena and Drug Product Development".

Technological innovations have become the impetus for continuous developments in medical research. With the assistance of new technologies, effective drug delivery techniques have been improved for optimal patient care. Recent Advances in Drug Delivery Technology is a pivotal reference source for the latest scholarly research on the application of pharmaceutical technology to optimize techniques for drug delivery in patients. Focusing on novel approaches in pharmaceutical science, this book is ideally designed for medical practitioners, upper-level students, scientists, and researchers.

How often do we stop to recognize what pharmaceutical advertisements are telling us? Broadcast Pharmaceutical Advertising in the United States: Prime Time Pill Pushers engages with this question to include how pharmaceutical companies are shaping the meaning of drug interventions for individuals and the ways in which pharmaceutical advertisements frame issues of identity and representation for patients and health care. Such issues highlight how patients are being framed as consumers in these advertisements, which then permits the commodification of health care to be celebrated. Such a celebration has strong ideological implications, including definitions of "the good life," patient agency, and the role of DTCAs in such depictions. By defining and discussing medicalization, pharmaceuticalization, and commodity fetishism, this book introduces how the term "pharmaceutical fetishism" can act as a means for describing the commodification of brand-name pharmaceutical drugs, which, via advertising and promotional culture, ignores large-scale production and for-profit motives of "big pharma."

This international directory of pharmaceutical manufacturers includes 1,046 firms in 50 countries. They are arranged alphabetically by country and company name.

In addition to name and address, other information such as telephone and fax number, and key personnel are also listed, where available.

Completing the directory, is a listing of 124 Contract Manufacturers in 19 countries of ethical and/or non-prescription pharmaceuticals. These are arranged alphabetically by country and company name.

Prozac. Paxil. Zoloft. Turn on your television and you are likely to see a commercial for one of the many selective serotonin reuptake inhibitors (SSRIs) on the market. We hear a lot about them, but do we really understand how these drugs work and what risks are involved for anyone who uses them? Let Them Eat Prozac explores the history of SSRIs-from their early development to their latest marketing campaigns-and the controversies that surround them. Initially, they seemed like wonder drugs for those with mild to moderate depression. When Prozac was released in the late 1980s, David Healy was among the psychiatrists who prescribed it. But he soon observed that some of these patients became agitated and even attempted suicide. Could the new wonder drug actually be making patients worse? Healy draws on his own research and expertise to demonstrate the potential hazards associated with these drugs. He intersperses case histories with insider accounts of the research leading to the development and approval of SSRIs as a treatment for depression. Let Them Eat Prozac clearly demonstrates that the problems go much deeper than a side-effect of a particular drug. The pharmaceutical industry would like us to believe that SSRIs can safely treat depression, anxiety, and a host of other mental problems. But, as Let Them Eat Prozac reveals, this "cure" may be worse than the disease.

This book explores the interplay between regulation and emerging technologies in the context of synthetic biology, a developing field that promises great benefits, and has already yielded fuels and medicines made with designer micro-organisms. For all its promise, however, it also poses various risks. Investigating the distinctiveness of synthetic biology and the regulatory issues that arise, Alison McLennan questions whether synthetic biology can be regulated within existing structures or whether new mechanisms are needed. Adopting an interdisciplinary approach, McLennan draws on diverse areas of law, the science of synthetic biology and the history and sociology of science. She concludes that synthetic biology presents novel regulatory challenges relating to environmental risk, biosafety, biosecurity and intellectual property. These challenges arise from the uniqueness of the science, the nature of its communities of scientists (including citizen scientists or 'biobunks') and the uncertainty surrounding possible hazards. Some scientists see intellectual property protection as a way to push innovation forward (bioentrepreneurs), while others openly share synthetic biology tools such as BioBricks. By understanding the range of regulatory challenges, the book make a case for enhanced regulation that protects us from synthetic biology's risks, whilst capturing its potential to improve our world. Regulation of Synthetic Biology will be essential reading for academics and students in the social sciences and law, as well as for scientists working in synthetic biology, and policymakers in innovation, science and the regulation of these fields.

The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. "Contract Research and Development Organizations: Their Role in Global Product Development" has been crafted by these authors to provide a how to guide for all aspects of working with CROs in selecting, working with and ensuring the best possible desirable outcome of having the R&D function, or substantial parts of it, outsourced. It uses as the exemplary case nonclinical safety assessment, biocompatibility and efficacy testing which are to be performed to select the best possible candidate compound, device or formulation and then moving the resulting regulated therapeutic medical product into and through the development process and to marketing approval. But also covered are the contract synthesis of drug substances and corresponding manufacture of biologics and manufacture of products, formulation development, clinical evaluation, regulatory and document preparation support, and use of consultants.

Included in the volume are an exhaustive listing of those CROs in the (drug and device) safety evaluation sector and their contact information and capabilities, and extensive similar listing for the other types of contract service providers. Also included are guidances on how to monitor ongoing work at contract facilities and audit check lists for GLP, GMP and GCP facilities. These listings are international in scope, and a specific chapter addresses working with some of the newer international CROs. "

This book provides an overview of the global pharmaceutical pricing policies. Medicines use is increasing globally with the increase in resistant microbes, emergence of new treatments, and because of awareness among consumers. This has resulted in increased drug expenditures globally. As the pharmaceutical market is expanding, a variety of pharmaceutical pricing strategies and policies have been employed by drug companies, state organizations and pharmaceutical pricing authorities.

Drug Law Reform in East and Southeast Asia is a multi-author look at drugs in East and Southeast Asia, on drug policy, patterns and trends, local problems, human rights abuses, treatment prospects, and potential reforms. From the history of drugs in Asia, the book examines recent trends in illicit drugs, especially the present enormous amphetamine problems. It addresses recent policy shifts, especially harm reduction responses to the devastating drug-associated HIV epidemics. It explores further necessary reform, especially in regard to the abysmally inhuman current emphasis on detention and the death penalty for drug offences, and present the most recent evidence on effective and humane approaches to drug treatments. As the first comprehensive collection on illicit drug and harm reduction in East and Southeast Asia, it will be a vital resource for health professionals, policymakers, and others working there and elsewhere on drug policy reform. As the first comprehensive collection on illicit drugs and harm reduction in East and Southeast Asia, it will be a vital resource for health professionals, policymakers, and others working on East and Southeast Asia--and elsewhere--on drug policy."

This book explains how government support and institutional set up facilitated the evolution of the Indian pharmaceutical industry and provides an economic analysis of firm strategies due to recent policy changes. The book is useful for researchers interested in understanding the transition of a lifeline sector for an emerging economy like India. Students of public policy, health administrators and health economists who are interested in the functioning of the pharmaceutical sector that produces life saving drugs in developing nations will find this book useful. The book also provides good coverage on data envelopment analysis (DEA), a useful technique for understanding productivity and efficiency. It can provide guidance to the research students on the applicability of DEA technique to address various research questions for analysis. The book will be a valuable addition to libraries in colleges of pharmacy and medicine as well as to all other academic and research centers.

This book examines how firms adapt to the pressures of increasing international competition by testing the arguments on "strategy specialization" proposed in the competitiveness literature in general, and by contributors to the "varieties of capitalism" debate in particular. If different economies are characterized by distinct institutional arrangements, successful firms would be those that exploit the related comparative advantages and specialize in the competitive strategies facilitated by national institutions.
One Political Economy, One Competitive Strategy? begins with an assessment of how many pharmaceutical firms in Germany, Italy, and the UK pursue strategies facilitated by national institutions governing the financial markets, antitrust activities, and the labor market. Quantitative analyses reveal that deviant firms, competing through institutionally unsupported strategies, outnumber conforming firms by far. Not only does this finding run counter to the expectations of the competitiveness literature, it brings up a whole new line of inquiry. How can firms compete through strategies that are not supported by national institutions? The book addresses this question and illustrates that firms do not necessarily exploit comparative institutional advantages, but that they can also circumvent institutional constraints. International markets and individual collaboration on a contractual basis allow firms to compete despite comparative institutional disadvantages. These findings suggest that trade liberalization does not lead to strategy specialization but to strategy diversification, depending on the inventiveness of entrepreneurs to develop individual approaches to compete.

Quality control in pharmaceutical products and medical devices is vital for users as failing to comply with national and international regulations can lead to accidents that could easily be avoided. For this reason, manufacturing a quality medical product will support patient safety. Microbiologists working in both the pharmaceutical and medical device industries face considerable challenges in keeping abreast of the myriad microbiological references available to them and the continuously evolving regulatory requirements. Quality Control Applications in the Pharmaceutical and Medical Device Manufacturing Industry presents the importance of quality control in pharmaceutical products and medical devices, which must have very high-quality standards to not cause problems to the health of patients. It reinforces and updates the knowledge of analytical, instrumental, and biological methods to demonstrate the correct quality control and good manufacturing practice for pharmaceutical products and medical devices. Covering topics such as pharmaceutical nano systems, machine learning, and software validation, this book is an essential resource for managers, engineers, supervisors, pharmacists, chemists, academicians, and researchers.

This book is open access under a CC-BY license. The importance of the pharmaceutical industry in Sub-Saharan Africa, its claim to policy priority, is rooted in the vast unmet health needs of the sub-continent. Making Medicines in Africa is a collective endeavour, by a group of contributors with a strong African and more broadly Southern presence, to find ways to link technological development, investment and industrial growth in pharmaceuticals to improve access to essential good quality medicines, as part of moving towards universal access to competent health care in Africa. The authors aim to shift the emphasis in international debate and initiatives towards sustained Africa-based and African-led initiatives to tackle this huge challenge. Without the technological, industrial, intellectual, organisational and research-related capabilities associated with competent pharmaceutical production, and without policies that pull the industrial sectors towards serving local health needs, the African sub-continent cannot generate the resources to tackle its populations' needs and demands. Research for this book has been selected as one of the 20 best examples of the impact of UK research on development. See http://www.ukcds.org.uk/the-global-impact-of-uk-research for further details.

Today, most people use prescription medications. Every year, the multi-billion dollar pharmaceutical industry produces new medicines that treat everything from arthritis to AIDS, from high cholesterol to depression. But, despite recent controversies regarding the safety of drugs, consumers know little about the medications that they ingest and inject. How are these new medicines invented? How do consumers know that drugs are safe and effective? How are they tested? Who regulates their production - and who watches the regulators? How do drug companies produce the vast quantities needed for the marketplace, and why do they market their drugs as they do? The New Medicines leads the reader through the maze of the modern drug industry - from bench to bedside - and provides consumers with a step-by-step understanding of how new medicines are created, approved, marketed, and sold. In addition to explaining how drugs reach the medicine cabinet, the author - an experienced researcher and teacher - provides the scientific and business background for understanding the current controversial issues surrounding new medicines, such as:

• The rise and fall of the COX-2 inhibitors, Vioxx and Celebrex, and the process by which they were invented, approved, and re-evaluated.
• The saga of the cancer drug Erbitux and its creator, the company Imclone, made famous as the centerpiece of the Martha Stewart insider-trading scandal
• The strengths and weaknesses of the approval process of the Food and Drug Administration
• The controversial new marketing techniques of the pharmaceutical industry

As governments seek to mitigate the cost of state-subsidized healthcare, branding in the pharmaceutical industry has become a critical issue. Drugs companies must change their methods of communication and distribution--focusing more on their direct relationship with the consumer. This requires fundamental changes in consumer behavior, access to information, freedom of choice, and value for money. Brands and brand values will play a leading role in this process, as has been seen with products such as Prozac and Viagra. This book by Interbrand Newell and Sorrell, the world's leading branding consultancy, provides cutting-edge thinking on this area and lessons for anyone involved in brand development and management.

Building Biotechnology helps readers start and manage biotechnology companies and understand the business of biotechnology. This acclaimed book describes the convergence of scientific, policy, regulatory, and commercial factors that drive the biotechnology industry and define its scope. In addition to its popularity among business professionals and scientists seeking to apply their skills to biotechnology, Building Biotechnology has also been adopted as a course text in dozens of advanced biotechnology programs. This fourth edition significantly expands upon the foundation laid by the first three, updating case law and business models in this dynamic industry and adding significantly more case studies, informative figures and tables. Most importantly, Building Biotechnology enables seasoned business professionals and entrepreneurial scientists alike to understand the drivers of biotechnology businesses and apply their established skills for commercial success.