"Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs."—Doody's Reviews, May 2009"The second edition of a book that offers a user-friendly step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of preclinical trials."—Chemistry World, February 2009The new edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products. Concise and easy to read, the book quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs.This second edition features many key enhancements, including Key Points, Chapter Summary, and Review Questions in each chapter, Answers to Review Questions provided in a book-end appendix, and one or two carefully selected "mini" case studies in each chapter.Richly illustrated throughout with over ninety figures and tables, this important book also includes helpful listings of current FDA and European guidelines and a special section on regulatory authority and processes in China. It is an indispensable resource for pharmaceutical industry and academic researchers, pharmaceutical managers and executives, healthcare clinicians, policymakers, regulators, and lobbyists with an interest in drug development. It is also an excellent textbook for students in pharmacy, science, and medicine courses.

Tells the remarkable story behind the revolutionary miracle cure for cancer, Gleevec, and describes its development by pharmaceutical company, Novartis.

The marketing planning system described in the second edition of this book has been designed to enable marketing and product executives in the pharmaceutical industry to produce a plan which serves as a dynamic management tool. A further orientation to external analysis and a reworking of the application of SWOT analysis, along with extra material on sales forecasting and strategy implementation are included.

This text focuses on development, manufacture, and commercialization of pharmaceutical protein dosage forms. The text envelops and emphasizes GMP attributes of quality, safety, purity, and strength. Each author provides practical, proven approaches and methods to achieve quality protein dosage forms on a commercial scale. No other book on protein goes into such practical detail on the requirements, and how to meet them, for developing, manufacturing, and gaining regulatory approval of protein dosage forms.

In this concise and systematic book, a team of experts select the most important, cutting-edge technologies used in drug delivery systems. They take into account significant drugs, new technologies such as nanoparticles, and therapeutic applications. The chapters present step-by-step laboratory protocols following the highly successful Methods in Molecular Biology™ series format, offering readily reproducible results vital for pharmaceutical physicians and scientists.

This practical manual provides a survey of the methods currently used in the design, conduct and analysis of clinical drug trials. Solutions to many controversial problems, based on the authors' extensive experience, are provided in this revised and updated edition of the text.

This book provides an excellent overview on state-of-the-art of modern organocatalysis. It presents the contributions from leading experts, with backgrounds in academia and industry, to an Ernst Schering Research Foundation Symposium held in April 2007. It will be of interest to those who want a general overview of the topic, but also to those who want to learn more about the state-of-the-art, current trends and perspectives in this highly dynamic field of research.

How many victims of cancer have thought, "If only I could order up a cure"?Rick Murdock could.In an extraordinary book that proves that truth can be stranger than fiction, Rick Murdock tells the dramatic story of his fight against a deadly lymphoma that could only be treated with technology developed by his own biotech company, and the equally harrowing battle for the survival of his company in a bruising legal dispute with a multibillion-dollar medical products giant.Rick Murdock was forty-four years old when he was named CEO of CellPro, a thriving biotech company in Seattle that was reaping the benefits of the biotech boom in the late 1980s and early '90s. Wall Street money fueled the flame of cutting-edge research at start-up companies like CellPro, where dedicated scientists were researching treatments that showed great promise in the fight against cancer and other diseases. But then Rick found a lump in his neck, evidence of the acute mantle cell lymphoma raging through his system. This rare form of cancer had no cure: Without a miracle, Rick would die.At CellPro, Rick found his miracle workers. In a stunning twist of fate, Rick's staff was experimenting with a radical new treatment for advanced lymphomas, though the scientists were months, if not years, away from success. Knowing they were their boss's last hope, these researchers went to work on the experiment that could save Rick's life. If they were successful, Rick would become "patient number one," the guinea pig for a technology that had never been used on humans.         The thrilling race against time to save Rick's life is only part of this remarkable story. For while Rick was fighting for his own life, he was also battling a medical products behemoth named Baxter Healthcare and archaic patent laws that threatened CellPro. If CellPro was put out of business, the promising therapies it had been developing for victims of breast cancer, leukemia, lymphoma, and other deadly cancers could disappear. Patient Number One shares the intriguing story of how entrepreneurs and scientists came together to form CellPro, painting a vivid picture of how researchers work tirelessly to come up with new and better treatments for disease, while their financiers play a high-stakes financial game to make money from these medical endeavors. However, in the tradition of books like A Civil Action, Patient Number One is also an illuminating, often scathing look at how medical research is conducted in America today as the bottom line can get in the way of saving lives. Lawyers, politicians, researchers, executives, and investors all want a piece of the biotech pie and will stop at nothing to preserve their special interests, even if it means keeping life-saving treatments from the people who need them.From tense courtroom scenes between the Goliath-like Baxter and tiny CellPro to anxious moments in the laboratory with Rick's staff and Rick's own agonizing cancer treatments, Patient Number One takes readers into the fascinating, frustrating world of medical research and how it directly affects us all.