Commercial pharmaceutical companies have been much criticised for their activities yet, at the same time, there is relatively little ethical information available to those working in the industry. This book addresses this need and develops pharmaceutical ethics as a field independent to medical ethics in general.

The combined experience of authors drawn from around Europe and the United States, currently working within and outside the Pharmaceutical industry, gives this book wide appeal. It should be read by anyone interested in the production and use of pharmaceuticals in contemporary society, be they established pharmaceutical scientists, pharmacy and medical practitioners, students just entering the profession, or interested lay persons.

Topics covered include:

• Ethical theory and the relationship between theory and real life decision-making

• The concept of informed consent

• The moral and political problems surrounding the use of pharmaceuticals in wider society

• The ethical responsibility in the choice of pharmaceutical agents and the cost of medicine related problems

• Ethical dilemmas of advertising, reimbursement and the affordability of medicines

• The ethical responsibility to the patient

Contents:
1. The Role of Drug Metabolism and Pharmacokinetics in Drug Discovery: Past, Present and Future 2. The Importance of the Physiochemical Properties of Drugs to Drug Metabolism 3. Sample Preparation 4. High Performance Liquid Chromatography in Pharmaceutical Bioanalysis 5. Quantitative Mass Spectronomy 6. Immunoassay in Bioanalysis 7. Phase I Metabolism 8. Phase II Enzymes 9. In vitro Techniques for Investigating Metabolism 10. Drug to Drug Interactions: an in vitro Approach 11. Clinical Impact of Drug Interactions 12. PreClinical Pharmacokinetics 13. Pharmacokinetic / Pharmacodynamic Modelling in PreClinical Drug Discovery 14. Toxicokinetics 15. Protein Binding in PlasmaA Case History of a Highly Protein Bound Drug 16. Metabolite Identification by Spectroscopy 17. Whole Body Autoradiography 18. Radiolabelled Studies in Man 19. Molecular Biology

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.

Five Stars. "Best book available if you want to learn about molecular techniques applied to clinical pathology." - Ruben A., Amazon Reviewer Five Stars. "Easy read. helped me to pass ASCP molecular bio certification exam." - Amazon Reviewer The only book you need to become certified. "Excellent book, full of details and clinical information. In addition, it describes very complexed concepts in a very easy way to understand including comprehensive diagrams." - Ruben G., Amazon Reviewer MB(ASCP) must read. "This is a must read for those laboratory professionals trying to advance their knowledge in molecular diagnostics especially for those people taking the MB(ASCP) exam. Sure it helped me pass the exam." - JR, Amazon Reviewer Meet the challenges of this rapidly expanding field: Molecular diagnostics continues to grow in importance in the clinical laboratory. This respected text will prepare your students with a grounding in the fundamental principles of molecular biology. current methods, and their clinical applications. With a focus on the application of molecular concepts to diagnostic purposes, the text explains and illustrate the use and interpretation of molecular-based assays in patient care. Now with an expanded discussion of nucleic acid sequencing, with added emphasis on next generation sequencing (NGS), and updated coverage of proteomics and mass spectrometry applications, your students will have the most current information available today.

"The most significant changes in isolation technology during the past five years have not been in the technology itself but in its increased acceptance. This acceptance is clearly demonstrated by the series of monographs, guidelines, and standards produced by regulatory bodies to describe best practice in the design and operation of isolators. Thoroughly revised and updated, Isolation Technology: A Practical Guide, Second Edition provides an in-depth overview of new standards and new technology. Here's what's new in the Second Edition: ""

For around half of the couples who have trouble conceiving the cause of infertility is sperm-related. Intracytoplasmic sperm injection (ICSI) is the most common and successful treatment for male infertility. Here, the pioneers for the technique, along with authorities in the field, describe the underlying science of ICSI and other micromanipulation techniques. Practical advice for performing the techniques is covered in depth, including sperm selection, laser-assisted ICSI, and the use of piezo in ICSI. Examining the safety of ICSI in animal models as well as the impact of ICSI on the health and well-being of the children conceived through the procedure is discussed. This manual is an essential resource for clinical embryologists and laboratory personnel wishing to refine or develop techniques and improve outcomes.

Clinical Chemistry: Principles, Techniques, and Correlations, Ninth Edition is the most student-friendly clinical chemistry text available today.

The Ninth Edition keeps students at the forefront of what continues to be one of the most rapidly advancing areas of laboratory medicine with clear explanations that balance analytic principles, techniques, and correlation of results with coverage of disease states.

The book not only demonstrates the how of clinical testing, but also the what, why, and when of testing correlations to help students develop the knowledge and interpretive and analytic skills they'll need in their future careers.

As with other volumes in the "Diagnostic Standards of Care series, Clinical Chemistry" focuses specifically on understanding potential problems and sources of error in management of the clinical chemistry testing procedures, how to anticipate and avoid such problems, and how to manage them if they occur. The discussions are concise, practical, specific, and problem-based so the book directly addresses the situations and issues faced by the clinical pathologist or other manager or staff member of the chemistry team. Discussion of each problem is augmented by a case discussion giving a real-world example of how the issue can occur and how it can be effectively dealt with by the manager. The goal is to support the pathologist, manager or technologist in providing the highest possible quality of care and effective, timely consultation to the clinical staff.

"Clinical Chemistry: Diagnostic Standards of Care" features Comprehensive coverage of key issues in achieving quality in all areas of clinical chemistry Includes chapters dedicated to point of care testing, pediatric testing, laboratory information systems and EHR integration, and outreach testing Numerous case examples and discussions give real-world illustrations of how problems occur and how to avoid them Coverage includes perspectives from the lab manager's and administrator's view An emphasis on identifying established, evidence-based standards in clinical chemistry Examples of errors which compromise patient safety across all major areas of clinical chemistry Pocket-sized for portability

An outstanding practical guide to the most common chemometric methods in use today

Chemometrics explains how to apply the most widely used pattern recognition and multivariate calibration techniques to solve data analysis problems. This practical guide describes all key methods in terms of processes and applications in order to help the reader easily identify the best technique for a given situation.

Drawing on years of industrial experience with chemometric tools, the authors share their six basic steps, or "habits," for achieving reliable chemometric results, and cover key areas such as:

• Defining and understanding the problem
• Experimental planning and design
• Preprocessing of samples and variables
• Supervised and unsupervised pattern recognition
• Classical and inverse methods of multivariate calibration

Complete with helpful chapter-end summaries, technical references, and more, this book is an invaluable hands-on resource for analytical chemists and laboratory scientists who use chemometrics in their work.

The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes.

...this is an excellent buy for anyone involved in drug development, risk assessment or within drug licensing agencies and in academic research...This book represents a benchmark achievement for this technique...it will become the standard for many years to come. - Paul Baldrick, British Toxicology Society Newsletter

Group sequential methods answer the needs of clinical trial monitoring committees who must assess the data available at an interim analysis. These interim results may provide grounds for terminating the study-effectively reducing costs-or may benefit the general patient population by allowing early dissemination of its findings. Group sequential methods provide a means to balance the ethical and financial advantages of stopping a study early against the risk of an incorrect conclusion.
Group Sequential Methods with Applications to Clinical Trials describes group sequential stopping rules designed to reduce average study length and control Type I and II error probabilities. The authors present one-sided and two-sided tests, introduce several families of group sequential tests, and explain how to choose the most appropriate test and interim analysis schedule. Their topics include placebo-controlled randomized trials, bio-equivalence testing, crossover and longitudinal studies, and linear and generalized linear models.
Research in group sequential analysis has progressed rapidly over the past 20 years. Group Sequential Methods with Applications to Clinical Trials surveys and extends current methods for planning and conducting interim analyses. It provides straightforward descriptions of group sequential hypothesis tests in a form suited for direct application to a wide variety of clinical trials. Medical statisticians engaged in any investigations planned with interim analyses will find this book a useful and important tool.

The Basic Bookshelf for Eyecare Professionals is a series that provides fundamental and advanced material with a clinical approach to clinicians and students. A special effort was made to include information needed for the certification exams in ophthalmic and optometric assisting, as well as for surgical assistants, opticians, plus low vision, and contact lens examiners. This book moves beyond basic exam skills into the arena of more advanced diagnostic testing. Topics include biometry and echography, electrophysiology, psychophysical testing, and microbiology. Special tests such as exophthalmometry, pachymetry, and ophthalmoscopy are also covered. This is the ultimate how-to book for those performing detailed patient exams.

Covering a wide range of research currently being done in drug analysi s, Drug Testing Technology: Assessment of Field Applications compares and evaluates various methods used to determine abused drugs taken by individuals, and their application in various programs and contexts. Controversies associated with various methods, including urine analysi s and hair analysis, are examined. Contributors from a wide diversity of disciplines offer advanced knowledge, encompassing work which is te chnical as well as markedly philosophical. Chapters provide overviews of drug incorporation into hair; the use of hair analysis for complia nce measurement in the use of anti-epileptic medications; and the appl ication of drug testing to the psychiatric treatment of substance abus e disorders. Drug Testing Technology: Assessment of Field Application s provides information useful in medical applications, workplace testi ng, criminal justice monitoring community epidemiology, and drug treat ment assessment.

This volume describes important medical discoveries, from the introduction of the first antibiotic to the present, where serendipity, intuition, coincidence, or laboratory accident played an important role in bringing a discovery to light. Although chance is the principal determinant, the book emphasizes other factors, such as economic and political exigencies and being in the right place at the right time.

This book covers the fundamental principles of fluorescence and their application to fluorescence microscopy, and presents applications to immunofluorescence, in situ hybridization, and photomicrography. It provides troubleshooting guidance to guide the user through commonly encountered problems.

I found this textbook to be a real bonus for my phlebotomy class. It had plenty of illustrations that complemented the text. I wound up getting an A in the class so I think the book is worth the money!" - Amazon Reviewer "Used this whole training for phlebotomy! Such a helpful informative book!" - Stacy T., Amazon Reviewer "Great book for a phlebotomy class. …lots of tips and warnings along with pertinent information and pictures." - Amazon Reviewer Enter the classroom and the laboratory with confidence! Rely on this comprehensive resource to master the techniques you need to safely obtain quality specimens. You'll understand all the hows and whys that lead to success in this rapidly changing field. Inside, you'll find the up-to-date coverage of routine procedures and their complications as well specialized procedures, quality and infection control, state-of-the-art equipment, medical terminology, ethical and legal issues, body systems, and related diagnostic laboratory tests. Videos and animations online help you to excel.

Molecular biology and genetics techniques now dominate viral research in attempts to cure diseases such as AIDS. Viral Genome Methods is a practical guide to the newest molecular techniques, providing step-by-step protocols to be used in the laboratory. Recognized authorities and pioneers in viral research pass on their expertise to you.

Examining the strengths and limitations of various standards of accuracy in clinical laboratory analyses, this detailed reference presents an in-depth study of important theoretical and empirical issues concerning the description, collection, and application of reference values in laboratory medicine.

The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes. Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook: Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.

Microspheres and Regional Cancer Therapy takes an interdisciplinary approach to the subject of microspheres and regional cancer therapy. It synthesizes laboratory and clinical data to demonstrate the utility of microsphere-based strategies in the treatment of localized solid tumors (particularly in the liver) not amenable to surgery and as a component of strategies for treatment of disseminated disease. Using the same techniques that show the deficiencies of delivery strategies involving antibodies, liposomes, and synthetic polymers, clear evidence is presented describing how microspheres of appropriate size can be localized in solid tumor deposits in the liver with little exposure to other organs. To exploit this phenomenon, the extent and nature of the incorporation of active agents within microspheres is discussed in relation to release, pharmacokinetics, and tumor response achieved by intensification of therapy in the manner described. This book will benefit laboratory-based scientists and clinicians in pharmaceutics, pharmacology, physiology, surgical oncology, and nuclear medicine. In addition, cancer clinicians interested in the value of regional therapy will be able to evaluate the underlying theory and learn the necessary methodology.

This book describes the methodology of monoclonal antibody-mediated immunohistochemistry, as applied to practical tissue diagnosis. It focuses on human disease and discusses the spectrum of monoclonal antibodies in relation to its utility in solving differential diagnostic problems.

This laboratory guidebook provides step-by-step procedures that will aid in the dissection and collection of major organs and tissues of the most common species of small animals used in biomedical research. Through extensive use of photographs and illustrations, the dissector is guided through a complete necropsy of each species for the purpose of collecting the organs and tissues routinely examined by pathologists. The techniques described will enable the technician to perform necropsies on almost any mammal in a precise and logical sequence, and to properly collect tissue in order to avoid diagnostic errors. Morphological differences among the various species are discussed.

This book focuses on instrumentation of chemi- and bioluminescence and discusses the nature of chemiluminescence as the exothermic oxidation of a substrate organic compound to give an energy-rich product that is luminescent. It describes the applications of chemiluminescence.

This text details the practical steps which must precede microscopy. Methods for preparing sheet or disk specimens and final thinning techniques are described with reference to practical problems. It also covers methods for mounting speciments in the TEM, and guides the reader on the most appropriate choice of speciment-preparation method.