The seventh edition of this concise, highly practical guide to the interpretation of normal and abnormal laboratory results is fully revised and expanded, with updates on established and familiar tests, as well as interpretations on recent developments. With increasing responsibility being placed on primary care, the book includes guidelines on specific clinical conditions such as heart failure, management of female infertility, specific lipid monitoring in diabetes and guidance for monitoring renal failure. It also includes suggestions for appropriate laboratory tests in certain clinical situations, for example: dementia screen, screening tests when a patient presents with a neuropathy, and appropriate tests for patients presenting with hypertension, chronic fatigue syndrome, erectile dysfunction and gynaecomastia. Completely up-to-date, A Guide to Laboratory Investigations, Seventh Edition remains an essential handbook for all primary care professionals professionals and a valuable reference for medical students and hospital physicians in training and in practice.

The perfect balance of theory and practice! Here's the practical introduction you need to understand the essential theoretical principles of clinical immunology and the serological and molecular techniques commonly used in the laboratory. You'll begin with an introduction to the immune system; then explore basic immunologic procedures; examine immune disorders; and study the serological and molecular diagnosis of infectious disease. An easy-to-read, student-friendly approach emphasizes the direct application of theory to clinical laboratory practice. Each chapter is a complete learning module with learning outcomes, chapter outlines, theoretical principles, illustrations, and definitions of relevant terminology. Review questions and case studies help you assess your mastery of the material. A glossary at the end of the book puts must-know information at your fingertips. An access code inside new printed texts unlocks Lab Exercises and Branching Case Studies online at FADavis.com that offer more opportunities to apply theory to clinical laboratory practice.

"No doctor, however great his capacity or original his ideas, has the right to choose martyrs for science or for the general good." Human Guinea Pigs: Experimentation on Man.Whistle-blowers tend not to be very popular. Maurice Pappworth's whistle was in the form of Human Guinea Pigs, the controversial book published in 1967 which examined unethical medical experimentation on humans and identified the researchers and institutions responsible. The ground-breaking text took the medical establishment by storm and provoked questions in Parliament. Brilliant, Jewish, already an outsider, Pappworth was recognised as the best medical teacher in the country. But convinced that the reason for these experiments being carried out was purely to advance the careers of ambitious practitioners, Pappworth had to speak up. In the wake of his expose, stricter codes of practice for human experimentation were put into place and the establishment of the research ethics committees was formed, which remains in place today. Maurice Pappworth's daughter, the late Joanna Seldon, re-assesses the importance of Human Guinea Pigs in her book Whistle-blower: The Life of Maurice Pappworth. She considers her father's text a major milestone in the development of current medical research ethics and demands a re-evaluation of the pioneering medical ethicist who compromised his own career in order to ensure the protection of the patient.

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.

Safely handle urine and body fluids | Process and analyze them effectively Here’s a comprehensive and highly visual introduction to the theoretical knowledge and practical skills needed to safely handle and analyze non-blood body fluids. The authors’ focused and reader-friendly approach begins with an emphasis on safety; introduces automation in urinalysis and body fluids analysis; and presents the foundational concepts of renal function and urinalysis. Then, step by step, you’ll learn the critical lab procedures for the examination of urine, cerebrospinal fluid, semen, synovial fluid, serous fluid, bronchoalveolar lavage fluid, amniotic fluid, feces, and vaginal secretions.

This combination manual and downloadable resources provide much-needed training on the proper handling of rats used in biomedical research. The downloadable resources include narrated video clips that demonstrate and describe each procedural technique. The manual contains handouts with color illustrations and descriptive text for each technique, including the purpose and application of the procedure, recommended skills, and necessary supplies. It can be used as a training resource and refresher for lab animal veterinarians, veterinary technicians, animal care staff, trainers, and research investigators and staff who work with rats.

Offers comprehensive coverage of currently available cancer predictors, the most recent research on carcinogenicity, and the design and interpretation of carcinogenicity experiments. Presents mouse, rat, and human carcinogenicity data for the liver, kidney, breast, cervix, prostate, hematopoietic system, colon, skin, urinary bladder, mouth, stomach, thyroid, and pancreas.

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.

In recent years, many animal-derived polymers have emerged as an attractive category of naturally derived polymers because of their advantageous physicochemical, chemical, and biological properties. The important biological properties of these natural polymers derived from animals are biocompatibility and biodegradation. These polymers are generally composed of repeated units of amino acids. Moreover, these polymers can be modified physically and/or chemically to improve their biomaterial properties. Natural Polymers for Pharmaceutical Applications, Volume 3: Animal-Derived Polymers looks at how these polymers can be exploited as pharmaceutical excipients in various pharmaceutical dosage forms, like microparticles, nanoparticles, ophthalmic preparations, gels, implants, etc. The commonly used animal-derived polymers used as pharmaceutical excipients are hyaluronic acid (hyaluronan), albumin, collagen, gelatin, chondroitin, etc.

The seventh edition of this concise, highly practical guide to the interpretation of normal and abnormal laboratory results is fully revised and expanded, with updates on established and familiar tests, as well as interpretations on recent developments. With increasing responsibility being placed on primary care, the book includes guidelines on specific clinical conditions such as heart failure, management of female infertility, specific lipid monitoring in diabetes and guidance for monitoring renal failure. It also includes suggestions for appropriate laboratory tests in certain clinical situations, for example: dementia screen, screening tests when a patient presents with a neuropathy, and appropriate tests for patients presenting with hypertension, chronic fatigue syndrome, erectile dysfunction and gynaecomastia. Completely up-to-date, A Guide to Laboratory Investigations, Seventh Edition remains an essential handbook for all primary care professionals professionals and a valuable reference for medical students and hospital physicians in training and in practice.

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.

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.

Contents:
Preface Acknowledgements The Pacific Theatre, World War II Introduction Part I. Japanese Factories of Death 1. Manchuria 2. Ishii Shiro 3. The Beiyinhe Bacteria Factory 4. Phase 1. Building Ping Fan 5. Phase 2. Hell in Ping Fan 6. The Secret of Secrets: Human Experiments 7. The Death Factory in Changchun 8. The Death Factory in Nanking 9. Experiments on prisoners of War 10. Who Knew? Part II. American Cover-Up The American Biological Warfare Program 12. Discovery of the Secret of Secrets 13. Investigations 14. Scientists and the Cover-Up 15. The Military and the Cover-Up 16. Epilogue Notes Select Bibliography Index

Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.

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.

Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provides comprehensive guidance on how to develop and execute biotech and other sterile drug facilities based on current industry best practices. Each chapter highlights a specific issue centered on managing biotech facilities projects in a GMP environment. The author uses real-world examples of common industry practice to lead you through the idiosyncrasies of a biotech project in an effort to answer some of the more common, and often perplexing, questions that can stand in the way of success. You get a mini seminar on each topic covered. Breaking the project life-cycle into four phases, the text takes you through each phase from the Project Manager's viewpoint. Unlike other books that cover design, technology, and validation in general terms, this book addresses the industry specific issues that make biotech facilities so costly and difficult to deliver. It puts the pieces of the puzzle together in a manner that increases your opportunity for success.

It is estimated that 80 to 90% of drugs under development never make it to the marketplace due to insufficient clinical activity, unacceptable toxicity, rapid appearance of drug resistance, or other factors that should be, at least partially, predictable from preclinical testing. This new text asks the question, "How can we use computational methods to improve the success rate in drug development?" Computer Techniques in Preclinical and Clinical Drug Development shows how modeling makes it possible to extract the maximum amount of information and predictive value from preclinical data. Computer modeling methods from the areas of pharmacokinetics, pharmacodynamics, cytokinetics, and inhibition kinetics of multi-enzyme pathways are all discussed in this unique reference source.

This practical book provides detailed guidance on all aspects of clean room airflow, the mechanics of airflow, and how microbial contamination is carried. Ljungqvist and Reinmuller draw on years of experience in clean room design and operation. The book contains maps of the effect of human interference on unidirectional airflow and the potential for contamination. Particle challenge test methods and tracer gas detection methods are explained, and the impact and interpretation of the results obtained from these test methods are discussed. Topics include: o Dispersion of Airborne Contaminants o Contamination Risks o Wakes (including factual situations) o Open, Unidirectional Air Flow Benches (laminar flow benches) o Microbiological Assessment o Weighing Stations o Air Flow Through Openings o Mathematical Treatment of Contamination Risks o Simulation of Air Flows & Dispersion of Contaminants through Doorways in a Suite of Clean Rooms o Regulatory Requirements

Offering a detailed, step-by-step guide to building a compliant cleaning validation program, Cleaning Validation: A Practical Approach covers trends in control, procedures, cleaning agents and tools, sampling techniques, analytical methods, and regulatory issues. The author provides practical examples, database formats, standard operating procedures, work instructions, protocols, and reports. He gives readers the tools they need to develop an effective and manageable program that will not only be acceptable to both US and non-US regulatory authorities but will conserve an organization's time, money, and people resources.

During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-use training tools. Until now. Cleaning Validation Manual: A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries elucidates how to train the man power involved in development, manufacturing, auditing, and validation of bio pharmaceuticals on a pilot scale, leading to scale-up production. With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors' more than two decades of experience in the pharmaceutical and biotech industries, the text offers hands-on training based on current approaches and techniques. The book does not merely provide guidelines or thought processes, rather it gives ready-to-use formulas to develop Master Plan, SOPs, and validation protocols. It includes cleaning procedures for the most commonly used equipment in various manufacturing areas and their sampling points, using a pharmaceutical manufacturing site with both sterile and non-sterile operations as the case facility. It also provides the training guidelines on downloadable resources to enable users to amend or adopt them as necessary. Grounded in practicality, the book's applicability and accessibility set it apart. It can be used as a guide for implementing a cleaning validation program on site without the help of external consultants, making it a resource that will not be found collecting dust on a shelf, but rather, referred to again and again.

ASCP requirement. "To pass the ASCP and become a licensed medical lab tech, this text is the ultimate blood bank source for the required classes." - Amazon Reviewer "Great resource for anyone in a Medical Technology or Medical Laboratory Science Program! I would highly recommend this book!" - Mary L., Amazon Reviewer "Amazing legendary book in the field. Helpful for practicing Transfusion Medicine and Hematology." - Zubair S., Amazon Reviewer Join the generations of students who have embarked on successful careers with a firm foundation in the theory and practice of blood banking and transfusion practices. Denise Harmening's classic text teaches you not only how to perform must-know tests and tasks, but to understand the scientific principles behind them. You'll begin with a review of the basic concepts of red blood cell and platelet preservation, genetics, immunology, and molecular biology. Then you'll move to the hows and whys of clinical practice. And, you'll be prepared for new advances in the field.

This work presents and evaluates methods employed to identify the potential of certain types of chemicals to adversely affect the skin. A variety of test methods are included such as tests for skin penetration, metabolism, irritation, the skin immune system, photo effects, skin cancer, and topical effects of retinoids and depigmenting chemicals. Tests for chemicals that affect the reproductive and nervous system are also included. Both animal and human tests that have been standardised and tests that are under development and employ animal alternatives are addressed in this book. Besides different testing methods, a rationale for accepting non-animal models and a review of some regulatory agency discussions about animal alternative tests are included.

Factories of Death details the activities of the Japanese army scientists that conducted numerous horrifying experiments upon live human beings. It investigates who from the upper echelons of the Japanese military and political establishments knew of the experiments, also the question of whether or not Allied POWs were subjected to such tests, and the nature of the deal that was brokered with US authorities after the war. This new edition has been completely updated, and contains an entirely new chapter detailing the numerous revelations that have surfaced since the book's initial publication in 1994.

Lab reports are used across a range of subjects, and they require very different skills to writing essays or literature reviews. Get the know-how you need to avoid losing marks and write your report with ease. Understand the structure so you know what's different before you start Avoid wasting time with insider tips on style and content Check your final report so you submit your best work. Super Quick Skills provide the essential building blocks you need to succeed at university - fast. Packed with practical, positive advice on core academic and life skills, you'll discover focused tips and strategies to use straight away. Whether it's writing great essays, understanding referencing or managing your wellbeing, find out how to build good habits and progress your skills throughout your studies. Learn core skills quickly Apply right away and see results Succeed in your studies and life. Super Quick Skills give you the foundations you need to confidently navigate the ups and downs of university life.

Whilst assisted reproduction techniques (ART) have become increasingly successful and largely standardized, there is still only a partial understanding of what constitutes a 'true' embryo environment. Replicating the varying physiological conditions of the in-vivo environment that the embryo travels through in the in-vitro culture is still a major challenge in ART. This practical volume details how to organize and operate an IVF laboratory in order to mimic these conditions for successful embryo culture. Environments and equipment that are essential for running safe and efficient facilities such as maintaining good air quality and hygiene protocols, and utilizing an effective layout are covered in detail. Other chapters discuss the different consumables needed, optimal handling techniques and parameter monitoring systems, as well as recent advances in the area including artificial intelligence and automation. This is an indispensable guide to understanding the background science of culturing embryos, crucial to successful outcomes in ART.