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.

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

"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: ""

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.

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.

Obtaining good quality oocytes and preparing them for in-vitro fertilization (IVF) is a key stage in assisted reproduction. This is a complex process with many pitfalls, making good clinical preparation and laboratory technique essential for success. Illustrated throughout, this book will be valuable to clinical embryologists, laboratory personnel wishing to redefine or develop technique and improve outcomes, IVF quality managers, and gynecologists performing oocyte retrieval. Featuring descriptions of the underlying science along with practical advice on methods and trouble-shooting, this comprehensive manual will aid all those involved in this complex process of oocyte retrieval and preparation in navigating towards optimal outcomes.

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.

...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

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.

Selecting the best embryo to transfer to the uterus is key to successful in vitro fertilization (IVF). A huge amount of research has been devoted to this topic and there are numerous methods used, from simple morphological assessment to molecular biological techniques to assess the genome and metabolism of the newly fertilized embryo. For many of these techniques, an adequate evidence base is lacking, and expert opinion is valuable. Clinical imperatives require ranking all embryos in a cohort according to their viability, thereby enabling the selection of the best embryo to optimize live birth outcome: a key indicator used to measure and rate IVF Clinics worldwide. This clear and informative manual will provide embryologists and clinicians with an overview of the tools now available to assist in embryo selection, as well as evidence for their efficacy and safety and the broader considerations that must underlie these important clinical decisions.

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.

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.

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.

With a strong emphasis on hands-on learning, this highly practical text helps you develop the phlebotomy-related knowledge and skills you need to become a confident, competent health care professional. The Fifth Edition accelerates learning by following key topics immediately with relevant exercises, integrating workbook elements and textbook content to deliver a complete learning experience. The text covers the latest professional standards and competencies while thoughtfully connecting them to the realities of practice today. Step-by-step guidelines for more than 20 collection procedures are provided, along with real-life scenarios and prompts emphasizing the phlebotomist's legal and ethical role in patient care decisions. Full-color photographs highlight important steps and relevant equipment, while illustrations depict anatomical components critical to proper technique. In addition, the digital edition includes videos and interactive exercises ideal for today's learners.

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.

This book provides an integrated description of methods used to rear vectors of human, higher animal, and plant pathogens in the laboratory. It deals with diverse subject areas, and contains descriptions of standard, as well as highly specialized, methods used by medical, veterinary, entomology, and plant pathology experts. The text brings together the standard breeding and manipulation methods developed in America, Europe, Asia, and Africa. It describes the cultivating, handling, sterile techniques, and cell culture as well as safety measures to prevent contamination and escape of insects, ticks, nematodes and fungal vectors.

The Essentials in Cytopathology book series fulfills the need for an easy-to-use and authoritative synopsis of site specific topics in cytopathology. These guide books fit into the lab coat pocket and are ideal for portability and quick reference. Each volume is heavily illustrated with a full color art program, while the text follows a user-friendly outline format. This new edition of Pulmonary Cytopathology is fully updated and expanded providing more detailed discussion of the role of new techniques such as EUS needle biopsy and specific issues of adequacy assessment. The section on subclassification of poorly-differentiated non-small cell carcinomas has been expanded to include accuracy of diagnosis in small samples, the new classification of adenocarcinoma and NSCC, currently-used ancillary techniques; i.e., immunohistochemistry, molecular/genetic techniques and therapeutic applications. Molecular techniques have been added as needed for targeted therapy. The text and illustrations have been expanded throughout.

In the literature of continuous flow analysis, there are hundreds of descriptions of problems encountered with the various AutoAnalyzer modules. This volume presents the way these have been used in conjunction with chromatographic separations and manufacturing plant process monitoring systems.

Rats have long been recognized as a valuable biomedical research model, notably in the investigation of aging, toxicology, addiction, and common human diseases such as diabetes and hypertension. In many instances, individuals conducting such research studies are charged with important responsibilities, including animal facility management, animal husbandry, veterinary care, regulatory compliance, and various experimental methodologies. With the advent of genetic manipulations and biomedical research technological advances such as bioimaging, the versatility and usefulness of the rat as an animal model has soared. The Laboratory Rat, Second Edition captures the multiple advances in this important animal model's husbandry, veterinary care, and experimental methodology. This edition features augmented, expanded, and novel information on biology, anesthesia, analgesia, and experimental techniques benefiting personnel working with rats-from the animal care staff to the researcher and everyone in between. The book is also extremely useful to institutional animal care and use program supporters and elements, including animal care and use committees, institutional officials, occupational health and safety professionals, veterinary technicians, and veterinarians.

Quality refers to the amount of the unpriced attributes contained in each unit of the priced attribute. Leffler, 1982 Quality is neither mind nor matter, but a third entity independent of the two, even though Quality cannot be defined, you know what it is. Pirsig, 2000 The continuous formulation of good practices and procedures across fields reflects the importance of the recognition and maintenance of "quality" for nearly every profession. The widespread introduction of point-of-care testing, centralization of activities in large core laboratories, and the increase in number and complexity of diagnostic testing worldwide has driven changes in the organization of laboratory diagnostics over the past decades. As such, laboratory diagnostics, continuously catching up to updated techniques and complex procedures, need to stay vigilant about safety and good practices adjustments. Although widely defined and quantified, the concept of quality is an intrinsic feature of the human psyche and decision making. Written to improve laboratory work, Quality Assurance in the Pathology Laboratory examines: Quality assurance of quantifiable methods applied in laboratory medicine and toxicology Quality aspects of emerging disciplines including personalized therapy and virtopsy Regulatory and logistic instrumentation that ensure quality in laboratory methods Professional education at the graduate and postgraduate levels Laboratory diagnostics substantially contributes to clinical decision making by providing valuable information for the screening, diagnosis, therapeutic monitoring, and follow-up of most-if not all-human disorders. Providing general insights into the quality assurance aspects of pathology and laboratory medicine, this book aids in improving laboratory work and, at the same time, shows the possibilities and limits of all logistic and legal tools related to quality issues.