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

The purpose of the book is to provide an overview of clinical research (types), activities, and areas where informatics and IT could fit into various activities and business practices. This book will introduce and apply informatics concepts only as they have particular relevance to clinical research settings.

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.

Today, biosensors are broadly applied in research, clinical diagnosis and monitoring, as well as in pharmaceutical, environmental or food analysis. In this work, the author presents the essentials that advanced students and researchers need to know in order to make full use of this technology. This includes a description of biochemical recognition elements, such as enzymes, antibodies, aptamers or even whole cells. Various signal transducers such as electrochemical and optical transducers, luminescence devices and advanced techniques such as quartz crystal microbalances and MEMS systems are covered as well. Current applications are introduced through various case studies, rounded out by a forward-looking chapter on the prospects for biosensor development offered by nanotechnology, lab-on-a-chip, and biomimetic systems.

This updated issue of Clinics in Laboratory Medicine, edited by Martin H. Bluth, will focus on Molecular Pathology. Topics include, but are not limited to, The Impact of Molecular Pathology on the Practice of Pathology; Molecular pathology techniques; Clinical Implication of MicroRNAs in Molecular Pathology; Diagnostic Molecular Microbiology; Molecular Pathology in Transfusion Medicine; Molecular Diagnosis of Hematopoietic Neoplasms; Molecular Diagnostics in Colorectal Carcinoma; Molecular Diagnostics in the Neoplasms of Small Intestine and Appendix; Molecular Diagnostics in Esophageal and Gastric Neoplasms; Molecular Diagnostics in the Neoplasms of the Pancreas, Liver, Gall Bladder, and Extrahepatic Biliary Tract; Current Applications of Molecular Genetic Technologies to the Diagnosis and Treatment of Cutaneous Melanocytic Neoplasms; Breast Carcinoma; and Gynecologic Cancers.

As the molecular basis of human disease becomes better characterized, and the implications for understanding the molecular basis of disease becomes realized through improved diagnostics and treatment, Molecular Pathology, Second Edition stands out as the most comprehensive textbook where molecular mechanisms represent the focus. It is uniquely concerned with the molecular basis of major human diseases and disease processes, presented in the context of traditional pathology, with implications for translational molecular medicine. The Second Edition of Molecular Pathology has been thoroughly updated to reflect seven years of exponential changes in the fields of genetics, molecular, and cell biology which molecular pathology translates in the practice of molecular medicine. The textbook is intended to serve as a multi-use textbook that would be appropriate as a classroom teaching tool for biomedical graduate students, medical students, allied health students, and others (such as advanced undergraduates). Further, this textbook will be valuable for pathology residents and other postdoctoral fellows that desire to advance their understanding of molecular mechanisms of disease beyond what they learned in medical/graduate school. In addition, this textbook is useful as a reference book for practicing basic scientists and physician scientists that perform disease-related basic science and translational research, who require a ready information resource on the molecular basis of various human diseases and disease states.

"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.

Laboratory Animals: Regulations and Recommendations for the Care and Use of Animals in Research, Second Edition, is the only publication to offer a global compilation of standards on the care, welfare and use of animals in research. The book provides updated information that will be of great interest to professionals across laboratory animal science and biomedical research. Users will find a broad picture of the regulations required in other areas of the world that will be essential to appropriately manage animal care and use programs.

This book discusses why specific diseases are being targeted for cell-based retinal therapy, what evidence exists that justifies optimism for this approach, and what challenges must be managed in order to bring this technology from the laboratory into routine clinical practice. There are a number of unanswered questions (e.g., surgical approach to cell delivery, management of immune response, optimum cell type to transplant) that very likely are not going to be answered until human trials are undertaken, but there is a certain amount of "de-risking" that can be done with preclinical experimentation. This book is essential reading for scientists, clinicians, and advanced students in stem cell research, cell biology, and ophthalmology.

Endocrine Biomarkers: Clinical Aspects and Laboratory Determination covers all the pre-analytical variables that can affect test results, both in the clinic and laboratory. Biomarkers of endocrine and bone diseases are discussed from both clinical and laboratory perspectives, and the authors elaborate on the teamwork-based app+roach between the clinician and the laboratory professional in the diagnosis and management of endocrine and bone disorders. Discussions include test utilization, laboratory measurement methods, harmonization and standardization, interpretation of results, and reference intervals. Each chapter ends with a discussion of one or two relevant cases with shared opinions from both a clinician and a clinical chemist. Each chapter also includes a summary box outlining key points and common pitfalls in the use of specific disease biomarkers and tests.

Designing EEG Experiments for Studying the Brain: Design Code and Example Datasets details the design of various brain experiments using electroencephalogram (EEG). Providing guidelines for designing an EEG experiment, it is primarily for researchers who want to venture into this field by designing their own experiments as well as those who are excited about neuroscience and want to explore various applications related to the brain. The first chapter describes how to design an EEG experiment and details the various parameters that should be considered for success, while remaining chapters provide experiment design for a number of neurological applications, both clinical and behavioral. As each chapter is accompanied with experiment design codes and example datasets, those interested can quickly design their own experiments or use the current design for their own purposes. Helpful appendices provide various forms for one's experiment including recruitment forms, feedback forms, ethics forms, and recommendations for related hardware equipment and software for data acquisition, processing, and analysis.

This publication represents the result of the fruitful workshop organised with the aim to attract the attention on the possibility of bio terrorism attack, with the s- port of NATO funds. In the last years the attention was strongly concentrated on the terrorism view similar to "military type attacks: " bomb on the trains, kamikazes, airplanes etc. As consequence many devices studied are directed to prevent these attacks such as the control of the passengers before the flight. For the people terrorism is therefore equivalent to bomb or similar and nobody think that there is also other possible and sophisticated means that can be used by the terrorist. In 1995 Sarin gas in the Tokio subway killed 12 people and affected 5,000 persons. In the USA anthrax was sent by mail to many federal offices. These events and other cases attract the attention on these possible terrorist attacks and the first recommendations for preventing theses events were\elaborated in the United State and in Europe. The possible agents and the modality that can be used for the diffusion are analysed and food and water are considered the principal and more favourable way. The story and the principal decision about this were reported in the first article of this collection which introduces the concept of bio-terrorism.

This issue of Clinics in Laboratory Medicine, edited by Drs. Anthony Odibo and David A. Krantz, covers issues surrounding Prenatal Screening and Diagnosis. Topics examined in this issue include, but are not limited to: Strategies for Implementing cfDNA Testing; Genetic Counselling for Patients Considering Screening and Diagnosis of Chromosomal Abnormalities; Microdeletions/Duplications; Sex Chromosome Abnormalities; First-, Second- and Third-Trimester Screening for Preeclampsia and Intrauterine Growth Restriction; Biophysicial/Biochemical Screening for the Risk of Preterm Labor; Preimplantation Genetic Testing; Toxoplasmosis, Parvovirus and Cytomegalovirus in Pregnancy; and Sleep Apnea and Adverse pregnancy Outcomes.

This issue of the Clinics in Laboratory Medicine, edited by Dr. Anil Parwani, is a special issue is devoted to topics in Pathology Informatics. Topics include but are not limited to: Basics of Information Systems (Hardware, Software); Networks, Interfaces and Communications; Databases; Data Representation, Coding and Communication Standards; Laboratory Information Systems; Enhancing and Customizing Laboratory Information Systems; Laboratory Management and Operations; Specialized Laboratory Information Systems; Middleware and Laboratory Automation; Bar Coding and Tracking; Molecular Pathology Informatics; Pathology Informatics and Project Management; Digital Imaging; Telepathology; Healthcare Information Systems; Data Security and Reliability; Role of Informatics in Patient Safety and Quality Assurance; Role of Pathology Informatics in IT Leadership; Selection and Implementation of New Information Systems; Biomedical Informatics and Research Informatics; Training in Pathology Informatics; and more.

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.

Clinical Diagnostic Tests is a convenient, quick-reference guide to common errors and pitfalls in test selection and result interpretation for practitioners and trainees in all areas of clinical medicine. Authored by recognized experts and educators in laboratory medicine, it provides timely, practical guidance about what to do?and what not to do?for practitioners ordering or interpreting clinical tests. Each topic features a concise overview and summary followed by a list of bulleted "standards of care" that will enable practitioners to quickly recognize and avert a potential problem.

"The Guide to Investigation of Mouse Pregnancy" is the first publication to cover the mouse placenta or the angiogenic tree the mother develops to support the placenta. This much-needed resource covers monitoring of the cardiovascular system, gestational programming of chronic adult disease, epigenetic regulation, gene imprinting, and stem cells.

Offering detailed and integrated information on how drugs, biologics, stress, and manipulations impact pregnancy in the mouse model, this reference highlights techniques used to analyze mouse pregnancy. Joining the ranks of much referenced mouse resources, "The Guide to Investigation of Mouse Pregnancy "is the only manual providing needed content on pregnancy in animal models for translational medicine and research.
Provides instruction on how to collect pre-clinical data on pregnancy in mouse models for eventual use in human applicationsDescribes the angiogenic tree the mother s uterus develops to support pregnancy and the monitoring of pregnancy-induced cardiovascular changesEducates readers on placental cell lineages, decidual development including immune cells, epigenetic regulation, gene imprinting, stem cells, birth and lactationDiscusses how stress, environmental toxicants and other manipulations impact upon placental function and pregnancy success
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This book summarizes the state-of-the art in the development of T cell-based "in vitro" assays, which offer useful tools for hazard identification, risk assessment and improvement of diagnostics. It will be of interest to scientists, the chemical and pharmaceutical industry, and regulators involved in the replacement of animal testing methods.

The identification of hazardous chemicals and drugs is essential to ensuring human health. The ban on animal testing for the cosmetics industry since 2009 and international efforts to reduce and replace animal testing in research and immunotoxicology call for alternative "in vitro" methods. The most specific immune response to chemicals and drugs that cause allergic contact dermatitis, respiratory disease and adverse drug reactions is the highly antigen-specific T lymphocyte response. Therefore the use of T cells as tools for identifying contact allergens and drugs that may cause health problems is of great interest.

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

This practical, easy-to-use guide, named to Doody s Core Titles 2013, addresses interference issues in all laboratory tests, including patient epigenetics, process of specimen collection, enzymes, biomarkers. Clinicians and laboratory scientists can therefore rely on one reference which speaks to both their needs of accurate specimen analysis and optimal patient care.

Erroneous hospital and pathology laboratory results can be confusing and problematic, especially in acute care situations. While some factors creating interference, can be identified in the laboratory, detecting many others is often dependent on clinical details unavailable to the laboratory scientists or pathologists. Therefore, clinicians must become proficient in identifying such erroneous reports, and working with pathologists and laboratory scientists so that they can understand the source of such interferences, correct the results, and then decide what course of action must be followed for proper patient management.
Named to Doody s Core Titles 2013, a collection development tool for health sciences libraries of all sizes, by Doody EnterprisesPractical information for both clinicians and laboratory scientists, presented in the form of tables and charts for easy referenceFocus on range and sources of interferences rather than details of toxicologic mechanisms which are well covered in toxicology textbooksCovers interferences across endocrine, oncology, hematology, immunohistochemistry, immunology, serology, microbiology, and molecular testing"

The textbook is based on the APPLIED use of laboratory instrumentation and apparatus in practice in the real working world with absolute minimum use of complex calculations and mathematics. Instrumental theory is kept to a minimum, with useful practical hints and unbiased instruction on lab instruments' capabilities and operations. All text is in simple to understand language of the complexities of chemical analyses.

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

Key topics in Pharmaceutical Computer Systems Validation, Second Edition include:

• GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP revisions to regulatory requirements for electronic records and signatures that should be published in 2008
• ICH Guidance Q8, Q9, and Q10 expectations
• FDA cGMPs for the 21st Century Initiative and associated guidance
• PIC/S Guidance on Good Practice for Computerized Systems in GxP Environments
• WK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
• the indirect developments from FDA/EU/Japan regulators and industry
• the role of QA department, and internal and external suppliers
• the integration of computer systems validation into single overall approach for wider system
• practical guidance on handling common high, medium, and low risk issues that can occur during the life cycle of a computer system
• managing outsource partners and handling legacy systems
• topical issues uncovered by regulatory authorities including US FDA

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.

The growing importance of the evidence-based movement has made experimental evaluation a key issue among researchers, practitioners, commissioners and policy makers. However, experimental evaluation remains controversial in the sexual health field. This partly reflects the diversity of groups involved in this area and their different views on the most appropriate research methods. This book provides an analysis of the methodological and practical issues involved in evaluating sexual health interventions.

The book will appeal to trial enthusiasts through discussion of specific issues in trial design, and also to those with a sceptical interest in the potential of experimentation and its appropriateness or feasibility. It is concerned with methodology rather than the substantive findings of research, and considers the requirements of research in both developed and developing countries. The focus of the book is on sexual health interventions, although many of the issues are equally applicable to other areas of behavioural and social research