This Sixth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject.

Using language and organization aimed directly at pharmacy technicians, Understanding Pharmacology for Pharmacy Technicians offers more than 700 pages of practical applications, safety issues and error prevention, and illustrative cases that not only explain how but why. Throughout the book, anatomy and physiology are discussed in relation to various disorders and associated pharmacotherapies to give the pharmacy technician students a context for how drugs work. Students using this book will learn the therapeutic effects of prescription medications, nonprescription medications, and alternative therapies commonly used to treat diseases affecting that system, and their adverse effects. An emphasis is placed on practical applications for the technician. What types of issues will technicians encounter at work? What is their role in patient education? How do they work with the pharmacist? Key features throughout the book: 77 case studies, including 249 case study questions More than 1,200 drugs discussed Pronunciations for difficult terms or words such as disease names Numerous figures and illustrations Alerts that point out areas of potential dangers or errors, including look-alike/sound-alike drugs. 335 practice points, including mention of any FDA-required patient medication guides, and any “special” drug storage and dispensing considerations, including beyond-use dating of open multi-use products. 110 commonly used and comprehensive drug tables. Chapter review questions The book’s content is written to meet ASHP accreditation standards and, therefore, is one of the most comprehensive books on the market related to pharmacology for technicians. For additional resources related to the book, visit www.ashp.org/techpharmacology.

Six Sigma in the Pharmaceutical Industry is the first book to introduce the fundamentals of Six Sigma, examine control chart theory and practice, and explain the concept of variation management and reduction applied specifically to the pharmaceutical industry. The first half lays 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. Providing the basis for a complete operating philosophy, this book focuses on core concepts and their implementation to improve the existing products and processes in the pharmaceutical industry.

Award-winning journalist and New York Times bestselling author Gerald Posner reveals the heroes and villains of the trillion-dollar-a-year pharmaceutical industry and delivers “a withering and encyclopedic indictment of a drug industry that often seems to prioritize profits over patients (The New York Times Book Review). Pharmaceutical breakthroughs such as anti­biotics and vaccines rank among some of the greatest advancements in human history. Yet exorbitant prices for life-saving drugs, safety recalls affecting tens of millions of Americans, and soaring rates of addiction and overdose on pre­scription opioids have caused many to lose faith in drug companies. Now, Americans are demanding a national reckoning with a monolithic industry. “Gerald’s dogged reporting, sets Pharma apart from all books on this subject” (The Washington Standard) as we are introduced to brilliant scientists, incorruptible government regulators, and brave whistleblowers facing off against company exec­utives often blinded by greed. A business that profits from treating ills can create far deadlier problems than it cures. Addictive products are part of the industry’s DNA, from the days when corner drugstores sold morphine, heroin, and cocaine, to the past two decades of dangerously overprescribed opioids. Pharma also uncovers the real story of the Sacklers, the family that became one of America’s wealthiest from the success of OxyContin, their blockbuster narcotic painkiller at the center of the opioid crisis. Relying on thousands of pages of government and corporate archives, dozens of hours of interviews with insiders, and previously classified FBI files, Posner exposes the secrets of the Sacklers’ rise to power—revelations that have long been buried under a byzantine web of interlocking companies with ever-changing names and hidden owners. The unexpected twists and turns of the Sackler family saga are told against the startling chronicle of a powerful industry that sits at the intersection of public health and profits. “Explosively, even addictively, readable” (Booklist, starred review), Pharma reveals how and why American drug com­panies have put earnings ahead of patients.

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.

Intended for use in an introductory pharmacology course, Basic Pharmacology: Understanding Drug Actions and Reactions provides an in-depth discussion of how to apply the chemical and molecular pharmacology concepts, a discussion students need for more advanced study. The textbook introduces the principles of chemistry and biology necessary to understand drug interactions at the cellular level. The authors highlight chemical and physical properties of drugs, drug absorption and distribution, drug interactions with cellular receptors, and drug metabolism and elimination. The book begins with a review of chemical principles as they apply to drug molecules, focusing mainly on those for commonly prescribed drugs. The authors use drug structures to illustrate the chemical concepts learned in general and organic chemistry courses. They cover the dynamics of receptors in mediating the pharmacological effects of drugs. They clarify theories, drawn from the scientific literature, which explain drug-receptor interactions and the quantitative relationship between drug binding and its effects at the cellular level. The authors’ extensive use of drug structures for teaching chemical and molecular pharmacology principles, and their emphasis on the relevance of these principles in future professional life makes this book unique. It provides the framework for better understanding of advanced pharmacology and therapeutics topics. Blending medicinal chemistry and pharmacodynamics aspects, this textbook clearly elucidates the essential concepts that form the cornerstone for further work in pharmacology.

Challenges our understanding of health, risks, facts, and clinical trials [Payot]