This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from …
A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators,…
This book overviews and integrates the business and technical issues that pharmaceutical companies need to know in order to combat the major global problem of counterfeit medicines. In addition to discussion of the problems, the author Davison addresses analytical techniques scientists use to detect counterfeits and presents some possible solutions to the threat of counterfeit medical products. Co…
Drug abuse has been, and continues to be, a global societal issue with diverse sets of impacts. Drugs of Abuse: Pharmacology and Molecular Mechanisms introduces the basic principles of pharmacology and neuroscience of drug abuse. Understanding the chemistry of commonly abused drugs and their impact on brain function will provide students and researchers with a more profound understanding of the mo…
Dr. Paris has written an honest, balanced presentation of the ways in which psychiatric drugs are evaluated and prescribed. He highlights the complexity of the task, the limits of what is known and the mixed picture that research often produces. His conclusions are refreshing because they are built from an even-handed, pragmatic assessment of the empirical evidence. The result is a stimulating loo…
This book covers the unique application of flow cytometry in drug discovery and development. The first section includes two introductory chapters, one on flow cytometry and one on biomarkers, as well as a chapter on recent advances in flow cytometry. The second section focuses on the unique challenges and added benefits associated with the use of flow cytometry in the drug development process. The…
This book bridges the gap between practitioners of supply-chain management and pharmaceutical industry experts. It aims to help both these groups understand the different worlds they live in and how to jointly contribute to meaningful improvements in supply-chains within the globally important pharmaceutical sector. Scientific and technical staff must work closely with supply-chain practitioners a…
The only book dedicated to physiologically-based pharmacokinetic modeling in pharmaceutical science Physiologically-based pharmacokinetic (PBPK) modeling has become increasingly widespread within the pharmaceutical industry over the last decade, but without one dedicated book that provides the information researchers need to learn these new techniques, its applications are severely limited. Descri…
This book, which is the translated version of a Swedish book, combines a general introduction of a variety of antibiotics with a more in-depth discussion of resistance. The focus on resistance in learning about antibiotics will help future scientists recognize the problem antibiotics resistance poses for medicinal and drug-related fields, and perhaps trigger more research and discoveries to fight …
Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, statistical data and results within drug development and clinical trials. It provides non-statisticians working in the pharmaceutical and medical device industries with an accessible introduction to the knowledge they need when working with statistical in…
The principles of drug therapies are fundamental to medical practitioners in all branches; but are often difficult to get to grips with. Prescribing at a Glance addresses the most common uses of prescription drugs, and follows progress from dose calculation, administration to monitoring the effects in the treatments of major presenting problems. With a focus on prescribing, this user-friendly guid…
Are you about to sit your pharmacology exams? Do you lack confidence in prescribing? Would it help to have a quick reference, pocket-sized reassurance on common drugs and the conditions that they are used in? The Hands-on Guide to Clinical Pharmacology is the perfect companion for students, doctors, nurses, pharmacists and other health care professionals who need help on the ward or are preparing …
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory …
Clinical Pharmacology and Therapeutics Lecture Notes provides a clear and accessible overview of all the key prescribing topics needed for medical finals and beyond. Detailed coverage and discussion of pharmacology in a clinical context, combined with an easy-to-understand, readable style, helps improve and test understanding of pharmacological principles and reasoning on rotation and into the fou…
This book reviews advances in understanding phosphodiesterases within the central nervous system and their therapeutic applications. A range of expert authors from both academia and industry describe these, then focus on the areas of greatest scientific and medical interest to provide more detailed coverage. Therapeutic and drug discovery applications are covered for diseases including Alzheimer's…