clinical research

The Design of Studies for Medical Research
The same careful rigour imposed on the design of phase III randomised controlled trials is not always applied to medical research in other areas such as trials conducted at earlier stages of drug development. With the emphasis that is now placed on evidence-based medicine, such care and rigour will inevitably impact on these areas with increasing attention turned to the quality of design. This title describes what principles can be used to structure research effectively allowing for the required degree of accuracy. Written by two best selling authors, this book includes many examples from medical literature and will be of great value to all groups conducting studies at the interface of clinical and laboratory research.

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Opioid Research: Methods and Protocols

Univ. of Texas MD Anderson Cancer Center, Houston. Text provides a comprehensive collection of methods and protocols used in current opioid research. Covers molecular and genetic techniques and behavioral analysis of animal models. Provides state-of-the-art techniques plus clinical applications. For researchers and practitioners.

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http://rapidshare.com/files/175661701/topresear_metho_proto.zip



Encyclopedia of Analytical Chemistry: Applications, Theory, and Instrumentation

The highly acclaimed Encyclopedia of Analytical Chemistry provides a much needed professional level reference work for the 21st Century. Encyclopedia of Analytical Chemistry is the most comprehensive analytical chemistry reference available, covering all aspects from theory and instrumentation through applications and techniques.

The chemistry and techniques are described as performed in the laboratory (environmental, clinical, QC, research, university), in the field or by remote sensing. The level of detail is similar to that of a lab protocol and together with the cited references, will support the analysis of complex inorganic, organic and biological structures by academic and industrial researchers. Encyclopedia of Analytical Chemistry also enables preparation of procedures, protocols and "cookbooks" by managers and staff of laboratories.

Encyclopedia of Analytical Chemistry comprises over 600 articles, arranged alphabetically by topic, in approximately 14000 pages, in 15 volumes.

Features:
* Outstanding authorship and the highest calibre editors
* Excellence of peer-review
* Article Summaries
* Over 6500 illustrations, many in colour
* Extensive cross-referencing to facilitate navigation between articles
* Extensive bibliographies with up-to-date references
Encyclopedia of Analytical Chemistry is the essential cross-disciplinary reference work for all analytical chemists in academia and industry. All fields of chemical research are covered: analytical, organic, physical, polymer, inorganic biomedical, environmental, pharmaceutical, industrial, petroleum, forensics and food science.

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http://rapidshare.com/files/167164034/tencyclo_ana_chem.zip


Pharmaceutical Experimental Design

This useful reference describes the statistical planning and design of pharmaceutical experiments, covering all stages in the development process-including preformulation, formulation, process study and optimization, scale-up, and robust process and formulation development. Shows how to overcome pharmaceutical, technological, and economic constraints on experiment design! Directly comparing the advantages and disadvantages of specific techniques, Pharmaceutical Experimental Design · offers broad, detailed, up-to-date descriptions of designs and methods not easily accessible in other books · reviews screening designs for qualitative factors at different levels · presents designs for predictive models and their use in optimization · highlights optimization methods, such as steepest ascent, optimum path, canonical analysis, graphical analysis, and desirability · discusses the Taguchi method for quality assurance and approaches for robust scaling up and process transfer · details nonstandard designs and mixtures · analyzes factorial, D-optimal design, and offline quality assurance techniques · reveals how one experimental design evolves from another · and more! Featuring over 700 references, tables, equations, and drawings, Pharmaceutical Experimental Design is suitable for industrial, research, and clinical pharmaceutical scientists, pharmacists, and pharmacologists; statisticians and biostatisticians; drug regulatory affairs personnel; biotechnologists; formulation, analytical, and synthetic chemists and engineers, quality assurance personnel; all users of statistical experimental design in research and development; and postgraduate and postdoctoral research workers in these disciplines.

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http://rapidshare.com/files/161402071/tpharma_exp_dgn.zip


Designing Clinical Research: An Epidemiologic Approach

Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology--including molecular and genetic clinical research--and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly.

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http://rapidshare.com/files/148468744/tdesigning_clin_rese.zip





Clinical Studies Management - A Practical Guide to Success

A comprehensive desk reference, this book provides an easy-to-read guide to the practical skills and methods required by project managers running clinical studies. The author uses a framework based on seven core themes: goals, budgets, time, resources, measurement, communication and training to present a solid review of how modern management theory can be brought to bear on the specialist demands of clinical trials. Coverage includes the R&D process, CROs, the Clinical Study Team, and QA audits. The book includes true-life case histories as well as a comprehensive overview of drug development processes and trends that are driving change. It is a resource for anyone who wishes to sharpen their study management skills.

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http://rapidshare.com/files/139169695/Csm_guide.zip


Laboratory Animal Law: Legal Control of the Use of Animals in Research

“It is hard to see how anyone with responsibilities under the Animals (Scientific Procedures) Act could manage without a book such as this.” Michael Balls, review published in Atla

“The strength of the book lies in the way Kevin Dolan brings his experience to bear blending information from various sources.” Patrick Sinnett-Smith, review published in RDS News

Written by the leading expert in this field, this is the only book providing practical guidance on the legal obligations of caring for laboratory animals. Up-to-date information on all relevant UK legislation and guidelines is given, with the main emphasis being on the interpretation of the Animals (Scientific Procedures) Act 1986.

New to this edition:

*Emphasis throughout is now on the practical application of legal controls of the use of animals in research.

*Updated where relevant to keep in line with new welfare legislation.

*Coverage of current format of application for personal and project licences.

*Expanded coverage of Certificates of Designation.

*Impact of the Freedom of Information Act is discussed.

A vital resource for all those involved with the use of animals in research, and especially those studying for qualifications or licences in this field.

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http://rapidshare.com/files/135449791/Lab_animal_law.zip


Conducting GCP- Compliant Clinical Research: A Practical Guide

Conducting GCP-Compliant Clinical Research Wendy Bohaychuk and Graham Ball Good Clinical Research Practices, UK and Canada The overall aim of this work is to provide a reference book which describes the general framework for conducting GCP-compliant clinical research, particularly pharmaceutical industry clinical research. Wendy Bohaychuk and Graham Ball run a consultancy, GCRP Ltd., which has conducted over 820 GCP audits involving more than 200 companies in the last 10 years. More than 5,000 individuals have been involved in their training courses to help people perform GCP-compliant clinical research. They have authored several books and articles including:
* Standard operating procedures for investigators
* Standard operating procedures for sponsors and CROs
* GCP - an indexed reference
Drawing on their wealth of experience, they have produced this enlightening and practical reference work which fills an educational gap in the understanding of GCP at all levels. Written in concise language simple enough to be accessible to those new in the field, the dozens of real-life stories and detailed case studies at the end of each chapter make the book an invaluable resource for the more experienced, highlighting what can go wrong in a clinical study: A study of prostate cancer in the UK - An investigator brochure was not provided. The company argued that a brochure was unnecessary because the drug was already marketed. Indeed it was - for hypertension! A study of cardiovascular surgery in the UK - The consent dates were changed (by overwriting) to indicate that the patients had provided consent before the study started. The original dates post-dated the start of the study. A study of hypertension in Germany - The investigator brochure predated the study by nine years! Checklists are provided throughout the book to help monitors, auditors and investigators ensure that nothing important is overlooked. The authors present the topic of GCP with remarkable clarity, insight and enthusiasm emphasizing that this code of practice was not designed to make studies more difficult for investigators or more expensive for sponsors and CROs but, in the final analysis, to ensure the safety and well-being of study participants and future patients who will benefit from well-conducted, GCP-compliant studies.

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http://rapidshare.com/files/133736102/tgcp_CR.zip


Good Clinical Practice: Standard Operating Procedures for Clinical Researchers

Good Clinical Practice Standard Operating Procedures for Clinical Researchers Edited by Josef Kolman MPRC - Medical Pharmaceutical Research Center Ltd. Vienna, Austria Paul Meng PMC - Dr Paul Meng Consultant, Vienna, Austria and Graeme Scott Professional Services in Clinical Research, Edinburgh, Scotland There is a growing trend for investigators to adopt a more formal approach to the procedures applied to various stages of clinical trials. Most environments employ some form of standard operating procedures which are designed to be used as 'working tools' within that particular field, e.g. standard operating procedures in hospitals for doctors and nurses. With rigorous standards of good clinical practice being applied to all areas, optimizing the design and use of standard operating procedures is more in demand every day. Topics covered include:

* A brief description of the history and development of clinical research and good clinical practice
* An explanation of what standard operating procedures are and how they work
* A selection of actual standard operating procedures and checklists
This well-constructed and timely work, set out in a logical, sequential order provides the necessary material needed to develop a useful set of investigator standard operating procedures.

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http://rapidshare.com/files/132314267/GCP_SOP_CR.zip


Practical Guide to Clinical Data Management

Clinical data management (CDM) has changed from being an essentially clerical task in the late 1970s and early 1980s to a highly computerized, highly specialized field today. Clinical data managers have had to adapt their data management systems and processes accordingly. Practical Guide to Clinical Data Management steers readers through the role of data management in clinical trials and includes more advanced topics such as CDM systems, SOPs, and quality assurance. It helps readers establish GCP, manage laboratory data, ensure that DMB systems are in compliance with federal regulations, and deal with the kinds of clinical data that can cause difficulties in database applications.

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http://rapidshare.com/files/126960497/Pra_gud_clin_dm2Ed.zip



Clinical Data Management

Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text is timely and an important contribution to the literature.
The volume:
* is written by well-known and experienced authors in this area
* provides new approaches to major topics in clinical data management
* contains new chapters on systems software validation, database design and performance measures.

It will be invaluable to anyone in the field within the pharmaceutical industry, and to all biomedical professionals working in clinical research.

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http://rapidshare.com/files/119011644/Clin_dta_mgmet.zip