Pharmacovigilance Database

Author: Ravi Humbarwadi
Editor: CreateSpace
ISBN: 9781507608128
File Size: 46,39 MB
Format: PDF
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PHARMACOVIGILANCE DATABASE. ORACLE ARGUS SIMPLIFIED OVERVIEW. Aris G, Oracle Argus, Empirica Trace, Sapphire, Clintrac are pharmacovigilance databases. This is an overview and gives a comprehensive insight that allows you an understanding of the databases currently in use in pharmacovigilance across the globe. Special Feature: Oracle Argus Specific Overview . Process- Book In to Medical Review. General Information - Reporter, Patient information to Pregnancy and Literature. Product - Suspect to Treatment Drug & Coding Modules. Event - Event input to Causality and Listedness Modules. Analysis - Narrative to Sender's comment. An End to End Field by Field and Module to Module Database Book.

Pharmacovigilance In Psychiatry

Author: Edoardo Spina
Editor: Springer
ISBN: 3319247417
File Size: 34,36 MB
Format: PDF, ePub, Docs
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The first authoritative textbook specifically addressing issues of the field, this book delivers a focused discussion on several themes in psychiatry while providing a sound background on pharmacovigilance. Internationally-recognised researchers, clinicians and pharmacovigilance experts contributed to this textbook, giving it the benefit of different perspectives and years of experience. Pharmacovigilance in psychiatry provides a thorough introduction to this field but goes on to explore advanced themes such as methodologies and resources used for pharmacovigilance in psychiatry, challenges as well as most recent developments to this field, making it suitable for under-graduates, graduate and post-doctoral students and persons working pharmacovigilance who seek to broaden their knowledge on this subject.

Pharmacovigilance

Author: Ronald D. Mann
Editor: John Wiley & Sons
ISBN: 0470059222
File Size: 12,73 MB
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Written by an international team of outstanding editors and contributors, Pharmacovigilance, 2nd Edition is the definitive text on this important subject. The new edition has been completely revised and updated to include the latest theoretical and practical aspects of pharmacovigilance including legal issues, drug regulatory requirements, methods of signal generation, reporting schemes and pharmacovigilance in selected system-organ classes. . The editors and contributors are of excellent standing within the pharmacovigilance community The text provides exemplary coverage of all the relevant issues The definitive book on the subject

Good Clinical Laboratory And Manufacturing Practices

Author: Phillip A. Carson
Editor: Royal Society of Chemistry
ISBN: 0854048340
File Size: 47,11 MB
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Spanning chemical, cosmetic and manufacturing industries, this book is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists.

Comparative Analysis Of French And Vietnamese Pharmacovigilance Databases With Pharmacoepidemiological Application And Improvement Of The Underreporting Of Adverse Drug Reactions In Vietnam

Author: Khac Dung Nguyen
Editor:
ISBN:
File Size: 56,72 MB
Format: PDF, Kindle
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The understanding and quantitative analysis in drug safety domain among developing countries remain still limited. The creation of the National Drug Information and Adverse Drug Reaction Monitoring Centre (NDIADRMC) of Vietnam in 2009 was a landmark for the pharmacovigilance activities in this country and allowed the registration of spontaneous adverse drug reaction (ADR) reports. The accumulation of National Pharmacovigilance Database of Vietnam (NPDV) requires a quantitative and qualitative analysis and generation of pharmacovigilance signals to better protect Vietnamese people's health. The main objectives of the thesis are: (i) describe the Vietnamese pharmacovigilance system, with the comparison to another developed pharmacovigilance system as a reference (France), (ii) apply a set of pharmacoepidemiological approaches to identify the specific drug-related risks, and (iii) improve the under-reporting issue in Vietnam. Firstly, we introduce a full-detailed overview of Vietnamese pharmacovigilance system with a series of lessons learned for the other countries sharing the similar limited-resource context. Some achievements and challenges for the sustainable development of the system were also equitably discussed. Secondly, we used the Vietnamese and French pharmacovigilance databases to compare the differences in characteristics of two types of ADR: anaphylaxis and Steven-Johnson's syndrome and toxic epidermal necrolysis (SJS/TEN) induced by medications. Next, we generated the first Vietnamese pharmacovigilance signals. The signals of drug-induced SJS/TEN were generated with allopurinol, carbamazepine, traditional or herbal drugs, colchicine, valproic acid and meloxicam which were similar to the other previously studies in literature. Furthermore, we also found the significant signals of cefixime and paracetamol. For drug-induced anaphylaxis, we identified 4873 (13.2%) cases in the Vietnamese database during the period 2010-2016 with an increasing trend over time. The antibiotics (especially the third-generation cephalosporins) were the main causes of drug-induced anaphylaxis in Vietnam. In addition, the signals were generated with several drugs such as alpha-chymotrypsin, amoxicillin/sulbactam and glucose or electrolyte solutions which were typical for the resource-restricted countries. On the other hand, the identification of ADR through the screening the laboratory test results could help to increase the ADR reporting rate in Vietnam. [...].

Veterinary Pharmacovigilance

Author: Kevin Woodward
Editor: John Wiley & Sons
ISBN: 9781444322941
File Size: 32,12 MB
Format: PDF, ePub
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Veterinary Pharmacovigilance: Adverse Reactions to Veterinary Medicinal Products is an in-depth examination of veterinary pharmacovigilance, looking at the scientific methodologies involved, the role of regulatory agencies and legislation, and the underpinning science. Edited by a renowned expert with over 20 years of experience in the field, it draws together the expertise of authors from around the world.

Pharmacovigilance A Practical Approach

Author: Thao Doan
Editor: Elsevier Health Sciences
ISBN: 032358117X
File Size: 62,23 MB
Format: PDF, Kindle
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Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Fabio Lievano, Mondira Bhattacharya, and Linda Scarazzini provide essential information for health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.

Pharmacovigilance Principles And Database Modules

Author: Ravi Humbarwadi
Editor: CreateSpace
ISBN: 9781507678886
File Size: 76,14 MB
Format: PDF, ePub
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Database Modules : Oracle ARGUS is the leading pharmacovigilance database . This book provides a detailed database, field by field description along with easy to understand graphic database modules used in drug safety.Pharmacovigilance Principles : MedDRA coding, GVP 2012, EMEA, FDA, Causality, Types of report and regulatory framework.The Pharmacovigilance Interview : A set of interview questions and answersSerious Vs Non - Serious : A set of serous versus non-serious scenarios to test your analysis skillsIME List : A comprehensive list of IME.

Drug Safety

Author: Ravi Humbarwadi
Editor: CreateSpace
ISBN: 9781511686785
File Size: 74,29 MB
Format: PDF
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Pharmacovigilance: The principles and practice of pharmacovigilance. Case processing guidelines and CIOMS format. With examples of MedDRA coding, regulatory process including EMEA, FDA and GVP 2012. List of IME (useful in day to day operations to help decide serious vs non-serious cases). Pharmacoepidemiology : Study Designs - Types designs and their use in different situations. Comprehensive description of NIS. Protocol, STROBE, ENCePP and Good pharmacoepidemiology Practices.Pharmacovigilance Database : Graphic Description. Field by Filed and Module by Module. Includes Overview of Oracle ARGUS. A MEGA BOOK OF DRUG SAFETY. Clear Any Interview. Get That Better Job.

New Scientist

Author:
Editor:
ISBN:
File Size: 77,93 MB
Format: PDF, Mobi
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Dictionary Of Pharmacovigilance

Author: Amer Alghabban
Editor:
ISBN:
File Size: 61,45 MB
Format: PDF, ePub
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Pharmacovigilance is, in essence, the process of monitoring the everyday use of medicines to identify previously unrecognized adverse drug reactions thereby assessing their risk/benefit balance in order to determine what action, if any, is necessary to improve their safe use by providing information to users to optimize safe and effective use while monitoring the impact of any action taken. The discipline along with its operational and legal facets, for both regulatory authorities and pharmaceutical industry, envelop colossal terminology that has precise legal and scientific significance. Such terminology may vary from country to country, or more confusingly, different countries may use identical or similar abbreviations, terms or phrases to mean different entities. This dictionary contains a list of abbreviations, terms and phrases (in English) giving definitions of commonly (and rarely) encountered pharmacovigilance terms.

Nursing Times Nursing Mirror

Author:
Editor:
ISBN:
File Size: 24,84 MB
Format: PDF, Kindle
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Bmj

Author:
Editor:
ISBN:
File Size: 42,98 MB
Format: PDF
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Evolving A Professional Pharmaceutical Distribution In Nigeria

Author: Nigerian Assembly of Industrial Pharmacists. Annual Conference
Editor:
ISBN:
File Size: 43,77 MB
Format: PDF, ePub, Docs
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Human Psychopharmacology

Author: Ian Hindmarch
Editor: Wiley
ISBN: 9780471950417
File Size: 59,57 MB
Format: PDF, Kindle
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Volume 6 of this invaluable series encompasses the increasing range of issues associated with psychopharmacology, giving up-to-date information not only on the scientific aspects of the subject but also on the social, legal and ethical implications. Chapters include: Stress, glucocorticoids and depression?implications for pharmacological intervention Pharmacovigilance and antidepressants Quality of life in psychopharmacology?what are we measuring and why does it matter? Legal aspects of drugs in the workplace Cognitive testing of new anticonvulsants Human Psychopharmacology: Measures and Methods has become established as a standard text in the subject, providing clear and authoritative treatments of the important and current issues in psychopharmacology. This volume will be an invaluable reference point for all those working in the area.

Pharmacoepidemiology

Author: Brian L. Strom
Editor: John Wiley & Sons Incorporated
ISBN:
File Size: 74,21 MB
Format: PDF, Mobi
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The Third Edition of this successful book has been revised and updated to include the latest advances in the field. It incorporates new topics such as prescription event monitoring, general practice research database, and drug utilization review. * Provides an American and European perspective. * The authors are renowned in the field.

A Practical Handbook On The Pharmacovigilance Of Antimalarial Medicines

Author: World Health Organization
Editor: World Health Organization
ISBN: 9241547499
File Size: 11,80 MB
Format: PDF
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The Handbook is a detailed manual giving a step by step approach to undertaking the pharmacovigilance of antimalarials. It is intended to be a source of practical advice for pharmacovigilance centres. It provides information on spontaneous reporting of adverse drug reactions as a complement to other WHO publications. In addition, it provides details on how to conduct cohort event monitoring, which is a method of active safety surveillance collecting information on all adverse events occurring after treatment. It also details how to perform causality assessment and signal identification, applicable to both methods of surveillance.

Information Industry Market Place 1983

Author:
Editor: R. R. Bowker
ISBN: 9780835215121
File Size: 79,91 MB
Format: PDF, Kindle
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Drug Information

Author: Bonnie Snow
Editor: Neal Schuman Pub
ISBN:
File Size: 71,44 MB
Format: PDF
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This is the long-awaited third edition of the most comprehensive compilation of drug information resources available. A co-publication with the Medical Library Association, it draws on industry expert Bonnie Snow's 30+ years of experience with pharmaceutical information needs and applications. Snow reviews 400+ print and electronic resources.More than a bibliography, this readable guide brings together the best resources plus practical advice on everything from expert search techniques to core collections for libraries. Subject areas covered include: pharmaceutical technology; legal and regulatory issues world-wide; industrial pharmacy; market research; product guides and prescribing information in the global marketplace; drug interactions; drug effects on pregnancy, lactation, and reproduction; pharmacovigilance; and much, much more. Completely revised, reorganized, and updated, the third edition focuses on information sources not covered elsewhere. Absolutely unique in its value as both a desk reference and a text for classroom use or self-study, this edition manages to meet the needs of students, information professionals, health care providers, and pharmacy practitioners.

Pharmacovigilance

Author: I. Ralph Edwards
Editor: Springer
ISBN: 3319404008
File Size: 75,22 MB
Format: PDF
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Written by experienced authors, this book offers expert personal views on what the current problems in pharmacovigilance are and how they should be solved. This book stems from thoughts and ideas discussed in a series of meetings of the International Society of Pharmacovigilance (ISoP), where concerns were raised that the current pharmacovigilance system is not delivering optimally to improve therapeutics in clinical practice. Pharmacovigilance of the future must be an active and integral part of health care delivery, and focus more on science and practices that support health professionals and patients in day-to-day care situations. To achieve this, a dynamic and sustainable development of vigilance must take precedence over the current excessive preoccupations with data processing and regulations; all aspects of medicines use and their effects need to be considered; and all stakeholders must be involved and engaged in an open and constructive debate. The work is essential reading for anyone who has an interest in safer use of medicines. It is intended to be equally challenging and rewarding, and sets out to stimulate a continuous debate on how pharmacovigilance can better meet the needs of health professionals and patients to achieve the aim of wise therapeutic decision making.