Clinical Drug Trials and Tribulations, Second Edition

Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on… · international regulation and deregulation · venture capitalist investment · the IND process · informed consent · changes in manufacturing and updated and extended coverage of… · pediatric drug trial design · the advantages and disadvantages of orphan drug designations · the maximization of package inserts for marketing · post approval safety surveillance · withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

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Encyclopedia of Clinical Pharmacy

This reference presents the latest procedures, practice guidelines, consensus documents, technological strategies, and regulatory standards for optimal pharmaceutical care--offering summaries for practical applications in a variety of clinical settings, including community and health-system pharmacies, clinics, hospice and long-term care facilities, government agencies, and pharmaceutical research and development organizations.

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Clinical Trial Risk Managment

Drug development is risky business. It is against the backdrop of huge financial, scientific, technical and medical risks that a clinical trials manager is expected to function, effectively identifying and managing all project risks, to deliver a successful outcome. Focusing on the day-to-day needs of a clinical trials manager, Clinical Trials Risk Management explains the key concepts and principles of risk management, as well as showing how best to how to apply them directly to ‘real life’ clinical trial situations. After building a foundation of basic principles, the authors lead you through specific methods for handling the risks characteristically encountered in clinical trials. Their combined years of experience in pharmaceutical research and development shine through the narrative, making the prose both lively and informative. They discuss concepts using worked examples and include a summary of the main points at the end of each chapter. In addition to diagrams and Risk and Precision Tree charts, the text is sprinkled with humorous line drawings that reinforce the concepts.

After reading this book, you will know how to:
# Prepare a Risk Assessment
# Design an Impact-Probability Matrix
# Compile a Risk Register
# Run a Monte Carlo Simulation
# Set up a Project Decision Tree
# Plan preventative and contingency actions.

The stand-alone chapters provide easy access to topics, while anecdotal and visual examples make them easy to remember. Martin Robinson and Simon Cook deliver a clear interpretation of complex information, thus saving you the time it would take to wade through a lengthier text, adopting a straightforward approach to examining clinical trials from a risk manager’s perspective. A practical, readable guide, the book is filled with information that can be put to immediate use to improve current or planned clinical trials.

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Side Effects of Drugs Annual 25, Volume 25: A world-wide survey of new data and trends in adverse drug reactions

•an essay by Dr Lara Marks, entitled 'The pill: untangling the adverse effects of a drug', invaluable for all workers in the field of Women's health and birth control, and
•a review of the adverse effects of Anthracycline Antibiotics by Dr Fraser and Dr Twelves, published as part of the chapter on 'Cytostatics' by Dr Andrew Stanley.
Other important features of this Annual are the many special reviews. An index of Special Reviews is published in the book. The special reviews are short articles that deal in depth with a specific topic of current interest, typographically distinguished from the rest of the text, and marked by the prescription symbol of the eye of Horus. The current Annual is enriched with the infamous 'Drug Index' and 'Index of Adverse Drug Reactions'.
Side Effects of Drugs Annual 25 is the second update of the encyclopaedic volume http://www.elsevier.nl/locate/isbn/0444500936Meyler's Side Effects of Drugs, Fourteenth Edition, which was published in 2000.

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A Manager's Guide to the Design and Conduct of Clinical Trials

Manager's Guide to the Design and Conduct of Clinical Trials
Pages: 248 Date: 2002 ISBN: 0471226157 Rared PDF File Rapidshare & Depositfiles 2 MB
This engaging and non-technical guide to clinical trials covers issues study design, organization, management, analysis, recruitment, reporting, software, and monitoring. Free from the jargon-laden treatment of other books, A Manager’s Guide to the Design and Conduct Clinical Trials is built upon the formula of first planning, then implementing, and finally performing essential checks.

Offers an executive level presentation of managerial guidelines as well as handy checklists accompanied by extracts from submitted protocols
Includes checklists, examples, and tips, as well as a useful appendix on available software Covers e-submissions and use of computers for direct data acquisition
Incorporates humorous yet instructive and true anecdotes to illustrate common pitfalls.

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Principles and Practice of Clinical Trial Medicine

Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, this book covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results.

 

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Clinical Trials - A Practical Guide to Design, Analysis, and Reporting

This book is a friendly jargon buster, which aims to demystify clinical trials. It is divided into five sections: fundamentals of trial design, alternative trial designs, basics of statistical analysis, special trial issues in data analysis, and reporting of trials. Using simple language the book explains with illustrations of numerous trial examples, the conceptual and methodological issues that occur at all stages of clinical trial covering trial design, conduct, analysis and reporting. The book is an educational and approachable reference in a difficult area of medicine where clinicians often feel uncertain and this material helps them review, appraise and publish trials and clinical evidence. The audience for the book includes physicians, statisticians, pharmacists, medical students, clinical researchers, medical writers, data managers, study co-ordinators, pharmaceutical sales representatives, and financial (medical) analysts.

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Statistics Applied to Clinical Trials

The previous two editions of this book, rather than being comprehensive, concentrated on the most relevant aspects of statistical analysis. Although well-received by students, clinicians, and researchers, these editions did not answer all their questions. This updated and extended edition serves as a more complete guide and reference text to students, physicians, and investigators, and, at the same time, preserves the common sense approach to statistical problem-solving of the previous editions.

In 1948 the first randomized controlled trial was published by the English Medical Research Council in the British Medical Journal. Until then, observations had been uncontrolled. Initially, trials frequently did not confirm hypotheses to be tested. This phenomenon was attributed to little sensitivity due to small samples, as well as inappropriate hypotheses based on biased prior trials. Additional flaws were being recognized and, subsequently were better accounted for: carryover effects due to insufficient washout from previous treatments, time effects due to external factors and the natural history of the condition under study, bias due to asymmetry between treatment groups, lack of sensitivity due to a negative correlation between treatment responses etc. Such flaws mainly of a technical nature have been largely implemented and lead to trials after 1970 being of significantly better quality than before. The past decade focused, in addition to technical aspects, on the need for circumspection in planning and conducting of clinical trials. As a consequence, prior to approval, clinical trial protocols are now routinely scrutinized by different circumstantial organs, including ethic committees, institutional and federal review boards, national and international scientific organizations, and monitoring committees charged with conducting interim analyses. The present book not only explains classical statistical analyses of clinical trials, but also addresses relatively novel issues, including equivalence testing, interim analyses, sequential analyses, meta-analyses, and provides a framework of the best statistical methods currently available for such purpose. This book is not only useful for investigators involved in the field of clinical trials, but also for students and physicians who wish to better understand the data of trials as published currently.

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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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Encyclopedia of Clinical Pharmacy

This reference presents the latest procedures, practice guidelines, consensus documents, technological strategies, and regulatory standards for optimal pharmaceutical care--offering summaries for practical applications in a variety of clinical settings, including community and health-system pharmacies, clinics, hospice and long-term care facilities, government agencies, and pharmaceutical research and development organizations.

 

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Drugs Compromising Male Sexual Health

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Drugs Compromising Male Sexual Health by Walter Krause
Publisher: Springer 2008-01 | 702 Pages | ISBN: 3540698590 | PDF | 2.8 MB

This concise drug guide lists 500 substances, such as pharmaceutical drugs, lifestyle drugs, and environmental toxicants, that show documented untoward effects on the male sexual organs and their functions. All substances are listed in user-friendly alphabetical order with a uniform structure throughout the book. Each listing includes evidence-based information with up-to-date references and all studies mentioned are evaluated and categorized according to study and sample types.

This unique compendium provides more detailed information on each drug than any other standard pharmacology title. Knowledge of the relevance of undesirable drug effects will enable the physician working in the fields of andrology and reproductive medicine to decide whether there is a relationship between a disturbance of male sexual function and a drugs adverse side effects. An electronic CD-ROM accompanies the book