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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Rifaximin, A Poorly Absorbed Antibiotic: Pharmacology and Clinical Use

Rifaximin is a semisynthetic rifamycin which is not absorbed from thegastrointestinal tract. It has been available in Europe and other countries for several years, and has recently been approved for treatment of traveler's diarrhea in the United States. Because of its broad spectrum of antimicrobial activity, rifaximin has been used with success in the treatment of infectious diarrhea, hepatic encephalopathy, small intestinal bacterial overgrowth, inflammatory bowel disease, and colonic diverticular disease. Potential indications include the irritable bowel syndrome and chronic constipation, Clostridium difficile infection and bowel preparation before colorectal surgery. In this publication both the present and future clinical use of rifaximin as well as the pharmacology behind it are extensively reviewed. Compiling the latest information on this remarkably active antibacterial agent, it will be an essential resource for infectiologists, gastroenterologists, and digestive surgeons alike.

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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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Cancer Chemotherapy Drug Manual 2008

Physician's Cancer Chemotherapy Drug Manual 2008
Jones and Bartlett Publishers Pages:552 2007-12-28 ISBN:0763755621 PDF 3 MB

Completely revised and updated for 2008, this practical handbook is an up-to-date guide to all aspects of cancer chemotherapy. The book provides a comprehensive, easy to use catalogue of over 100 drugs-both on- and off-label-commonly used in cancer treatment. A section on Common Chemotherapy Regimens provides a quick reference to management of specific cancers, arranged alphabetically.

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complete Therapeutic Guidelines - July 2008 (FULL)

The aim of Therapeutic Guidelines Limited (TGL) is to provide clear, practical, authoritative and succinct therapeutic information for busy health practitioners, for the management of patients with specific conditions.
The recommendations in Therapeutic Guidelines are based on the latest international literature, interpreted by some of Australia’s most eminent and respected experts, with each statement having been examined, subjected to challenge and discussed over a series of day long meetings. The finished texts represent the essence of current available evidence.
The aim of Therapeutic Guidelines Limited (TGL) is to provide clear, practical, authoritative and succinct therapeutic information for busy health practitioners, for the management of patients with specific conditions.
The guidelines are comprehensive in that they cover all common disorders seen in clinical practice. The information is independent and unbiased and is a distillation of current evidence and opinion. The text is arranged into chapters and sections according to diagnostic entities. Each section gives sufficient surrounding information to orient the reader followed by succinct and explicit recommendations for therapy.
The guidelines are not primarily meant to instruct, but rather to assist prescribers in ensuring patients receive optimum treatment.
The content of each title is revised by an expert group every 3 to 4 years. The iterative cycles are based on response to feedback, and shifts in the evidence base.
The essential principles underlying this process for guideline development stem from the production of the first guidelines in 1978, with the method being both refined and improved over the years.

CHM Format

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FASTtrack: Therapeutics

Nadia Bukhari, David Kearney, "FASTtrack: Therapeutics"
Pharmaceutical Press 2009 ISBN: 0853697752 200 pages PDF 3,3 MB

This is a revision guide for students providing bullet points of basic information on therapeutics. "FASTtrack" is a new series of indispensable revision guides created especially. The content of each title focuses on what pharmacy students really need to know in order to pass exams, providing concise, bulleted information, key points, tips and an all-important self-assessment section which includes MCQs, case studies, sample essay questions and worked examples. The "FASTtrack" series provides the ultimate lecture notes and is a must-have for all pharmacy undergraduate students wanting to revise and test themselves for forthcoming exams. A "FASTtrack" website includes MCQs, sample online content and much more.\

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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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Non-Prescription Medicines, Fourth Edition

Non-Prescription Medicines, Fourth Edition
By Alan Nathan
 

•Publisher:  Pharmaceutical Press
•Number Of Pages:   308
•Publication Date:   2010-06-17
•ISBN-10 / ASIN:   0853698864
•ISBN-13 / EAN:   9780853698869

Product Description:
 

This new edition has been revised and updated to reflect amendments in legal category status of several products from prescription-only (POM) to pharmacy sale (P) status.
Over-the-counter (OTC) medicines currently available in the UK are reviewed in alphabetically arranged chapters on the conditions that they are licensed to treat. 44 common conditions are covered and new chapters on Chlamydia, Obesity and Benign Prostatic Hyperplasia have been added.
•an introduction to the condition
•detailed description of the available products, including mode of action, side-effects, cautions and contraindications, interactions and dosage
•product selection points
•product recommendations.
Non-prescription Medicines is the only publication in the UK that deals with available OTC medicines comprehensively and in depth. This vital resource will enable pharmacists, GPs, nurses and other healthcare professionals to make well-informed recommendations and to give sound advice to their patients.

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Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care (16th Edition)

•Publisher:  American Pharmacists Association
•Number Of Pages:   1050
•Publication Date:   2009-03-30
•ISBN-10 / ASIN:   1582121222
•ISBN-13 / EAN:   9781582121222

Size: 233 MB

Thoroughly updated and revised, the Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care, 16th edition, helps students and practitioners develop problem-solving skills needed to assess and triage a pharmacy patient s medical problems. It provides U.S. Food and Drug Administration-approved dosing information and evidence-based research on the efficacy and safety of over-the-counter and herbal medications.
Key Features:
Contributors include more than 70 academics and practitioners from multiple health care fields with expertise in non-prescription medications and devices and other self-care options.
Updated information and references and new, improved anatomical drawings are included.
An enhanced complementary and alternative medicine section provides readers with a broad overview of different healing practices that patients may be using.
New information on emergency contraception is provided.
Disease-oriented chapters contain new and revised case studies, treatment algorithms, comparisons of self-treatments, patient education boxes, product selection guidelines, and tables that list interactions as well as dosage and administration guidelines.
The Key Points section at the end of the chapters highlights important concepts.
Free eBook download with purchase of the textbook makes the entire content fully searchable on your computer. Available on Pharmacy Library.

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Adverse Drug Interactions: A Handbook for Prescribers

Year/2009
Pages/849
Size/2MB

The prescription of two or more drugs for simultaneous use by a patients always raises the possibility that one of those drugs will affect the intensity and duration of effect of the other(s), and can introduce the possibility of serious side effects occurring. This book provides a convenient, user-friendly approach to this problem, providing information on potential adverse affects by drug class. By establishing a system of grading throughout the book and appropriate coding through the use of special icons, the authors highlight immediately to the reader those interactions that are likely to give rise to life-threatening reactions and must therefore be completely avoided in addition to other, less threatening but nonetheless important interactions to be aware of. Presented in tabular form for ease of reference, the book also provides a brief summary of the mechanism underlying a particular interaction, alternative drugs lacking the same reactions that may be considered and instructions for monitoring patients when adverse effects may occur. All advice is supported by the appropriate evidence, graded according to a university accepted system. Drug naming follows the recommendations of INN. Throughout, interactions with OTC medications, herbal remedies and dietary supplements are also considered.

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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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Basic & Clinical Pharmacology

Now in its 25th year of publication, Basic and Clinical Pharmacology is the most up-to-date and complete pharmacology textbook available. Through nine previous editions it has set the standard for concise and easy-to-read, yet comprehensive coverage of pharmacology. The text's integration of basic with clinical science makes it well suited for an integrated organ-system-based curricula as well as the more traditional curricula.

Features:

In-depth coverage of key pharmacology topics, from basic principles to pharmacologic considerations for autonomic, cardiovascular-renal, smooth muscle, CNS, endocrine, antimicrobial, and chemotherapeutic and immunotherapeutic drugs

Updated with dozens of new, recently approved drugs, including monoclonal antibodies

Detailed review of the mechanism of action and toxicities of traditional and newer drugs

Critical discussions of treatment strategies and recommended drugs for all major disease

Valuable section on toxicology that provides an introduction to occupational and environmental toxicology; heavy metal intoxication and chelators; and management of the poisoned patient

Ready-to-use, study-enhancing features, including special interest boxes, lists of common preparations, and dosage informatio

Unique evidence-based chapters on abused drugs; special aspects of perinatal, pediatric, and geriatric pharmacology; and over-the-counter drugs, herbal medications, and nutritional supplement

More than 500 concept-clarifying illustrations and tables throughout

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