Red Book

Red Book
Author: Thomson
Publisher: Wiley-Blackwell
Total Pages: 0
Release: 2008
Genre: Medical
ISBN: 9781563636714

The new "2008 Red Book" not only presents the latest pricing and product information on more than 160,000 prescription and over-the-counter items, but also a complete list of newly FDA-approved brands, generics, and biologics.

FDA in the Twenty-First Century

FDA in the Twenty-First Century
Author: Holly Fernandez Lynch
Publisher: Columbia University Press
Total Pages: 499
Release: 2015-09-08
Genre: Business & Economics
ISBN: 0231540078

In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.

Trissel's Stability of Compounded Formulations

Trissel's Stability of Compounded Formulations
Author: Lawrence A. Trissel
Publisher: American Pharmacists Association (APhA)
Total Pages: 456
Release: 2000
Genre: Medical
ISBN:

"Helps readers determine whether formulated compounds will be stable for the anticipated duration of use; properly store and repackage compounded formulations; formulate in accordance with documented standards; and, counsel patients on the use and storate of comounded medications." -- Back cover.

Basic Principles of Drug Discovery and Development

Basic Principles of Drug Discovery and Development
Author: Benjamin E. Blass
Publisher: Academic Press
Total Pages: 738
Release: 2021-03-30
Genre: Science
ISBN: 0128172150

Basic Principles of Drug Discovery and Development presents the multifaceted process of identifying a new drug in the modern era, which requires a multidisciplinary team approach with input from medicinal chemists, biologists, pharmacologists, drug metabolism experts, toxicologists, clinicians, and a host of experts from numerous additional fields. Enabling technologies such as high throughput screening, structure-based drug design, molecular modeling, pharmaceutical profiling, and translational medicine are critical to the successful development of marketable therapeutics. Given the wide range of disciplines and techniques that are required for cutting edge drug discovery and development, a scientist must master their own fields as well as have a fundamental understanding of their collaborator's fields. This book bridges the knowledge gaps that invariably lead to communication issues in a new scientist's early career, providing a fundamental understanding of the various techniques and disciplines required for the multifaceted endeavor of drug research and development. It provides students, new industrial scientists, and academics with a basic understanding of the drug discovery and development process. The fully updated text provides an excellent overview of the process and includes chapters on important drug targets by class, in vitro screening methods, medicinal chemistry strategies in drug design, principles of in vivo pharmacokinetics and pharmacodynamics, animal models of disease states, clinical trial basics, and selected business aspects of the drug discovery process. - Provides a clear explanation of how the pharmaceutical industry works, as well as the complete drug discovery and development process, from obtaining a lead, to testing the bioactivity, to producing the drug, and protecting the intellectual property - Includes a new chapter on the discovery and development of biologics (antibodies proteins, antibody/receptor complexes, antibody drug conjugates), a growing and important area of the pharmaceutical industry landscape - Features a new section on formulations, including a discussion of IV formulations suitable for human clinical trials, as well as the application of nanotechnology and the use of transdermal patch technology for drug delivery - Updated chapter with new case studies includes additional modern examples of drug discovery through high through-put screening, fragment-based drug design, and computational chemistry

Key Concepts in Drugs and Society

Key Concepts in Drugs and Society
Author: Ross Coomber
Publisher: SAGE
Total Pages: 439
Release: 2013-04-29
Genre: Social Science
ISBN: 1446291367

′This is a great resource that reflects the huge expertise of the authors. It will be welcomed by students, researchers and indeed anyone wanting critical but comprehensive coverage of key issues and trends concerning drugs and society - locally and globally, historically and today.′ - Nigel South, Professor of Sociology, University of Essex ′Provides informative, balanced and contextualized insights into the relationships between people and drugs. Whatever your background and however knowledgeable you feel you are about contemporary drug issues, I guarantee that you will learn something unexpected and new from this valuable text.′ - Joanne Neale, Professor of Public Health, Oxford Brookes University Why do people take drugs? How do we understand moral panics? What is the relationship between drugs and violence? How do people′s social positions influence their involvement in drug use? Insightful and illuminating, this book discusses drugs in social contexts. The authors bring together their different theoretical and practical backgrounds, offering a comprehensive and interdisciplinary introduction that opens up a wide scientific understanding moving beyond cultural myths and presuppositions. This is an invaluable reference source for students on criminology, sociology and social sciences programmes, as well as drug service practitioners such as drug workers, social workers and specialist nurses.

Drugs and Drug Policy

Drugs and Drug Policy
Author: Mark A.R. Kleiman
Publisher: Oxford University Press
Total Pages: 258
Release: 2011-07-13
Genre: Political Science
ISBN: 0199831386

While there have always been norms and customs around the use of drugs, explicit public policies--regulations, taxes, and prohibitions--designed to control drug abuse are a more recent phenomenon. Those policies sometimes have terrible side-effects: most prominently the development of criminal enterprises dealing in forbidden (or untaxed) drugs and the use of the profits of drug-dealing to finance insurgency and terrorism. Neither a drug-free world nor a world of free drugs seems to be on offer, leaving citizens and officials to face the age-old problem: What are we going to do about drugs? In Drugs and Drug Policy, three noted authorities survey the subject with exceptional clarity, in this addition to the acclaimed series, What Everyone Needs to Know®. They begin, by defining "drugs," examining how they work in the brain, discussing the nature of addiction, and exploring the damage they do to users. The book moves on to policy, answering questions about legalization, the role of criminal prohibitions, and the relative legal tolerance for alcohol and tobacco. The authors then dissect the illicit trade, from street dealers to the flow of money to the effect of catching kingpins, and show the precise nature of the relationship between drugs and crime. They examine treatment, both its effectiveness and the role of public policy, and discuss the beneficial effects of some abusable substances. Finally they move outward to look at the role of drugs in our foreign policy, their relationship to terrorism, and the ugly politics that surround the issue. Crisp, clear, and comprehensive, this is a handy and up-to-date overview of one of the most pressing topics in today's world. What Everyone Needs to Know® is a registered trademark of Oxford University Press.

Statistical Issues in Drug Development

Statistical Issues in Drug Development
Author: Stephen S. Senn
Publisher: John Wiley & Sons
Total Pages: 523
Release: 2008-02-28
Genre: Medical
ISBN: 9780470723579

Drug development is the process of finding and producingtherapeutically useful pharmaceuticals, turning them into safe andeffective medicine, and producing reliable information regardingthe appropriate dosage and dosing intervals. With regulatoryauthorities demanding increasingly higher standards in suchdevelopments, statistics has become an intrinsic and criticalelement in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents anessential and thought provoking guide to the statistical issues andcontroversies involved in drug development. This highly readable second edition has been updated toinclude: Comprehensive coverage of the design and interpretation ofclinical trials. Expanded sections on missing data, equivalence, meta-analysisand dose finding. An examination of both Bayesian and frequentist methods. A new chapter on pharmacogenomics and expanded coverage ofpharmaco-epidemiology and pharmaco-economics. Coverage of the ICH guidelines, in particular ICH E9,Statistical Principles for Clinical Trials. It is hoped that the book will stimulate dialogue betweenstatisticians and life scientists working within the pharmaceuticalindustry. The accessible and wide-ranging coverage make itessential reading for both statisticians and non-statisticiansworking in the pharmaceutical industry, regulatory bodies andmedical research institutes. There is also much to benefitundergraduate and postgraduate students whose courses include amedical statistics component.

Therapeutic Drug Monitoring

Therapeutic Drug Monitoring
Author: Amitava Dasgupta
Publisher: Academic Press
Total Pages: 469
Release: 2012-06-07
Genre: Medical
ISBN: 0123854687

Therapeutic Drug Monitoring: Newer Drugs and Biomarkers features timely topics such as the monitoring of classical and newer drugs, pharmacogenomics and the application of biomarkers in therapeutic drug monitoring. This reference also discusses the limitations of current commercially available immunoassays for therapeutic monitoring. It presents new and sophisticated techniques used for proper determination of blood levels and the clinical utility of therapeutic drug monitoring of contemporary drugs. Written by leading international experts and geared toward clinical pathologists, toxicologists, clinical chemists, laboratory professionals and physicians, this book is an essential resource on the current practice of therapeutic drug monitoring in improving patient safety. - Includes both the technical and clinical issues associated with therapeutic drug monitoring - Discusses the utility of therapeutic drug monitoring of newer drugs such as antiretroviral agents, anticonvulsants, antidepressants etc. - Provides up-to-date information on issues in pharmacogenomics and personalized medicine with emphasis on therapy with warfarin, certain anticancer drugs and antidepressants - Covers important content on the limitations of commercially available immunoassays (chemical tests) for therapeutic drug monitoring and additional analytical techniques