Guidelines on Representative Drug Sampling


Book Description

The present guidelines describe a number of sampling methods, from arbitrary methods with a statistical background. They focus on sampling in cases where large numbers of relatively homogeneous material are available. They do not deal with so-called tactical sampling, which may be applied for house-searches or in clandestine laboratory investigations. Its aim is to support drug analysis laboratories in the selection of their sampling strategies and best working practices.




Sampling Essentials


Book Description

Written for students taking research methods courses, this text provides a thorough overview of sampling principles. The author gives detailed, nontechnical descriptions and guidelines with limited presentation of formulas to help students reach basic research decisions, such as whether to choose a census or a sample, as well as how to select sample size and sample type. Intended for students and researchers in the social and behavioral sciences, public health research, marketing research, and related areas, the text provides nonstatisticians with the concepts and techniques they need to do quality work and make good sampling choices.







Workplace Drug Testing


Book Description

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.




The Use of Drugs in Food Animals


Book Description

The use of drugs in food animal production has resulted in benefits throughout the food industry; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industriesâ€"poultry, dairy, beef, swine, and aquaculture. The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease. The committee offers analysis and insight into these areas: Monitoring of drug residues. The book provides a brief overview of how the FDA and USDA monitor drug residues in foods of animal origin and describes quality assurance programs initiated by the poultry, dairy, beef, and swine industries. Antibiotic resistance. The committee reports what is known about this controversial problem and its potential effect on human health. The volume also looks at how drug use may be minimized with new approaches in genetics, nutrition, and animal management.




Improving Health Research on Small Populations


Book Description

The increasing diversity of population of the United States presents many challenges to conducting health research that is representative and informative. Dispersion and accessibility issues can increase logistical costs; populations for which it is difficult to obtain adequate sample size are also likely to be expensive to study. Hence, even if it is technically feasible to study a small population, it may not be easy to obtain the funding to do so. In order to address the issues associated with improving health research of small populations, the National Academies of Sciences, Engineering, and Medicine convened a workshop in January 2018. Participants considered ways of addressing the challenges of conducting epidemiological studies or intervention research with small population groups, including alternative study designs, innovative methodologies for data collection, and innovative statistical techniques for analysis.




Sample Preparation of Pharmaceutical Dosage Forms


Book Description

This book is intended to serve as a resource for analysts in developing and troubleshooting sample preparation methods. These are critical activities in providing accurate and reliable data throughout the lifecycle of a drug product. This book is divided into four parts: • Part One covers dosage form and diluent properties that impact sample preparation of pharmaceutical dosage forms and the importance of sampling considerations in generating data representative of the drug product batch. • Part Two reviews specific sample preparation techniques typically used with pharmaceutical dosage forms. • Part Three discusses sample preparation method development for different types of dosage forms including addressing drug excipient interactions and post extraction considerations, as well as method validation and applying Quality by Design (QbD) principles to sample preparation methods. • Part Four examines additional topics in sample preparation including automation, investigating aberrant potency results, green chemistry considerations for sample preparation and the ideal case where no sample preparation is required for sample analysis.




Quality assurance of pharmaceuticals: a compendium of guidelines and related materials, tenth edition. Volume 1. Good practices and related regulatory guidance


Book Description

This publication represents a significant achievement in our ongoing effort to ensure that everyone can reach the highest possible level of health. Over the last three decades, we have seen the transformation of the pharmaceutical industry and the increasing intricacy of the product life cycle. The challenges we face today are very different from those we faced when the first edition of this Compendium was published in 1997. However, our mission remains the same: to promote health, keep the world safe and serve the vulnerable. The new edition reflects the collective knowledge and expertise of countless professionals who have worked diligently to develop, revise, and implement WHO guidelines for pharmaceuticals. This includes experts from WHO, Member States, our Expert Advisory Panels and Expert Committees on Specifications for Pharmaceutical Preparations and other organizations and has undergone extensive consultation with stakeholders worldwide. This Compendium covers development through manufacturing and quality control to post-marketing surveillance. It provides a comprehensive framework for quality assurance that is both strong and flexible, capable of meeting the requirements of a rapidly changing global health landscape. The 10th edition is a collection of knowledge and tools for empowerment, enabling all stakeholders in the pharmaceutical industry to make informed decisions that prioritize patient safety and well-being.




Bacteriological Analytical Manual


Book Description




Holland-Frei Cancer Medicine


Book Description

Holland-Frei Cancer Medicine, Ninth Edition, offers a balanced view of the most current knowledge of cancer science and clinical oncology practice. This all-new edition is the consummate reference source for medical oncologists, radiation oncologists, internists, surgical oncologists, and others who treat cancer patients. A translational perspective throughout, integrating cancer biology with cancer management providing an in depth understanding of the disease An emphasis on multidisciplinary, research-driven patient care to improve outcomes and optimal use of all appropriate therapies Cutting-edge coverage of personalized cancer care, including molecular diagnostics and therapeutics Concise, readable, clinically relevant text with algorithms, guidelines and insight into the use of both conventional and novel drugs Includes free access to the Wiley Digital Edition providing search across the book, the full reference list with web links, illustrations and photographs, and post-publication updates