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

A precise, practical handbook, Clinical Laboratory Investigation and Psychiatry is an invaluable tool that explores day-to-day psychiatric practices and various situations that arise in the field of mental health. This unique and resourceful textbook is a must-have aid for front-line clinicians, psychiatrists, and other professionals working in the field of adult mental health.

This complete guide to clinical psychiatry:

• examines methods for improving patient care and clinical outcomes
• extensively investigates which blood samples and tests to consider when dealing with mental health patients
• illustrates the possible clinical outcomes and interprets them in an easy-to-access format
• deals with the complexities of patients under difficult circumstances
• guides clinicians through the proper use of the clinical laboratory

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

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.

Animal experimentation has long been a controversial issue, with impassioned arguments on both sides of the debate. Increasingly, it has become more expedient and feasible to develop new methods that avoid the use of animals. There is agreement on both sides that reduction and refinement of experiments on animals should be an important goal for the industries involved. Alternatives to Animal Testing, written by leading experts in the field, discusses the issues involved and approaches that can be taken. Topics included are: the safety evaluation of chemicals; international validation and barriers to the validation of alternative tests; in vitro testing for endocrine disruptors; intelligent approaches to safety evaluation of chemicals; alternative tests and the regulatory framework. The book provides an up-to-date discussion of the current state of development of alternatives to animal testing and is ideal for professionals and academics in the field. It would also be of use for graduate students wishing to pursue a career in the pharmaceutical and cosmetics industries.

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.

...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

"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 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.

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 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.

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 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.

Infection by flaviviruses such as dengue virus serotypes (DENV 1-4), Japanese encephalitis virus (JEV), tick-borne encephalitis virus (TBE), yellow fever virus (YFV) and West Nile virus (WNV) impact millions of lives and cause tens of thousands of mortalities each year. Dengue is a global public health emergency especially since there is no preventative vaccine or antiviral treatment for dengue disease. Dengue: Methods and Protocols offers the increasing number of dengue researchers a one-stop protocol book with techniques compiled from the leading laboratories working on dengue. Chapters cover topics such as dengue virus isolation from clinical samples, quantification of human antibodies against the virus, assays to quantify the virus particles, the widely used mouse model to study dengue pathogenesis, vaccine and antiviral efficacies. Written in the successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible protocols and notes on troubleshooting and avoiding known pitfalls. Authoritative and easily accessible, Dengue: Methods and Protocols seeks to serve both professionals and novices with its well-honed methodologies on dengue research.

Overgrowth Syndromes is a comprehensive clinical guide to the well-defined genetic disorders (and others that are less well-defined) for which somatic overgrowth is a major manifestation. It details the unique characteristics and known causative genes for this class of disorders, offering clinicians an expert resource for both clinical diagnosis and laboratory confirmation. Assembled by the world's leading experts on overgrowth, this volume maximizes clinical utility without sacrificing nuance or rigor. It codifies the last decade's sweeping advances in understanding general and segmental overgrowth, including the latter's mosaic nature and phenotypic variability. It is an essential resource for clinicians navigating this set of conditions from clinical presentation all the way to counseling and anticipatory management.

Volume 68 in the internationally acclaimed Advances in Clinical Chemistry contains chapters authored by world renowned clinical laboratory scientists, physicians and research scientists. The serial provides the latest and most up-to-date technologies related to the field of Clinical Chemistry and is the benchmark for novel analytical approaches in the clinical laboratory.