This book provides a step-by-step guide to simple methods for verifying the identity of commonly used pharmaceutical substances and dosage forms. The basic tests described can also be used to detect mislabeled, substandard, or counterfeit products when the labeling or physical attributes give rise to doubt. Intended for use in developing countries, where resources and specialized skills may be scarce, all tests rely on a limited range of easily available reagents and equipment and need not be performed in a fully equipped laboratory or by persons with specialized training in pharmacy or chemistry. The book describes tests for 23 pharmaceutical substances and 58 pharmaceutical dosage forms, most of which are included in the WHO Model List of Essential Drugs. Basic tests for confirming the identity of four commonly used medicinal plant materials are also included. As stressed in the text, these tests, which merely confirm identity, are intended for use as primary screening tools and may need to be followed, in cases of adverse test results, by a full pharmacopoeial analysis. The book opens with a brief description of the importance of basic tests as one of the many steps needed to ensure a supply of safe and effective drugs. Chapter two describes several collections of more sophisticated tests, including volumetric or spectrophotometric analysis and thin-layer chromatography, that can be useful in the primary screening of imported pharmaceutical substances, and dosage forms. Information on how to obtain and use these guides to tests, which have not been published by WHO is also provided. Against this background, the main part of the book sets out test procedures for verifying the identity of selected pharmaceutical substances, pharmaceutical dosage forms, and medicinal plant materials. The book concludes with a cumulative index of test procedures described here and in the related WHO publications "Basic Tests for Pharmaceutical Substances" and "Basic Tests for Pharmaceutical Dosage Forms".

The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

A time-saving, stress-reducing approach to learning the essential concepts of pharmacology Great for USMLE review! "This could be a very useful tool for students who struggle with understanding the most basic concepts in pharmacology for course and licensure examinations. 3 Stars."--Doody's Review Service Basic Concepts in Pharmacology provides you with a complete framework for studying -– and understanding -- the fundamental principles of drug actions. With this unique learning system, you’ll be able to identify must-know material, recognize your strengths and weaknesses, minimize memorization, streamline your study, and build your confidence. Basic Concepts in Pharmacology presents drugs by class, details exactly what you need to know about each class, and reinforces key concepts and definitions. With this innovative text you’ll be able to: Recognize the concepts you truly must know before moving on to other material Understand the fundamental principles of drug actions Organize and condense the drug information you must remember Review key information, which is presented in boxes, illustrations, and tables Identify the most important drugs in each drug class Seven sections specifically designed to simplify the learning process and help you gain an understanding of the most important concepts: General Principles Drugs That Affect the Autonomic Nervous System Drugs That Affect the Cardiovascular System Drugs That Act on the Central Nervous System Chemotherapeutic Agents Drugs That Affect the Endocrine System Miscellaneous Drugs (Includes Toxicology and Poisoning)

Science, Medicine, and Animals explains the role that animals play in biomedical research and the ways in which scientists, governments, and citizens have tried to balance the experimental use of animals with a concern for all living creatures. An accompanying Teacher's Guide is available to help teachers of middle and high school students use Science, Medicine, and Animals in the classroom. As students examine the issues in Science, Medicine, and Animals, they will gain a greater understanding of the goals of biomedical research and the real-world practice of the scientific method in general. Science, Medicine, and Animals and the Teacher's Guide were written by the Institute for Laboratory Animal Research and published by the National Research Council of the National Academies. The report was reviewed by a committee made up of experts and scholars with diverse perspectives, including members of the U.S. Department of Agriculture, National Institutes of Health, the Humane Society of the United States, and the American Society for the Prevention of Cruelty to Animals. The Teacher's Guide was reviewed by members of the National Academies' Teacher Associates Network. Science, Medicine, and Animals is recommended by the National Science Teacher's Association NSTA Recommends.

This comprehensive text provides clear explanations of the effects of drugs on human performance and the need for workplace drug testing. It provides essential information on the regulatory and legal frameworks around the world, how to set policies and coverage of all aspects of drug analysis and the associated interpretation of results.Contents include:* epidemiology of drug use in the working population* the evidence base and guidelines for workplace drug testing* legal, regulatory aspects and policies for drugs and alcohol* urine and alternative sample collection process* analytical techniques and specimen adulteration.Case studies of successful programmes are also included to illustrate the principles discussed.Written by internationally acknowledged experts this informative book will be essential reading for anyone interested in workplace drug testing or setting up such a system including clinical and forensic toxicologists, occupational health physicians, nurses, human resources, drug counselling and treatment providers, analytical chemists and lawyers.Alain Verstraete is Professor at the Department of Clinical Chemistry, Microbiology and Immunology, Ghent University, Ghent, Belgium and Department Head of the Toxicology Laboratory of the Laboratory of Clinical Biology, Ghent University Hospital, Ghent, Belgium.

A collection of test procedures for assessing the identity, purity, and content of medicinal plant materials, including determination of pesticide residues, arsenic and heavy metals. Intended to assist national laboratories engaged in drug quality control, the manual responds to the growing use of medicinal plants, the special quality problems they pose, and the corresponding need for international guidance on reliable methods for quality control. Recommended procedures - whether involving visual inspection or the use of thin-layer chromatography for the qualitative determination of impurities - should also prove useful to the pharmaceutical industry and pharmacists working with these materials.

Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.

The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.