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Post Authorization Safety Studies Of Medicinal Products

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Post Authorization Safety Studies of Medicinal Products

Post Authorization Safety Studies of Medicinal Products Book
Author : Ayad K. Ali,Abraham G. Hartzema
Publisher : Academic Press
Release : 2018-06-27
ISBN : 0128092084
Language : En, Es, Fr & De

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Book Description :

Post-Authorization Safety Studies of Medicinal Products: The PASS Book bridges the gap in the literature by providing a complete look at post-authorization safety studies and important pharmacoepidemiology and pharmacovigilance aspects. It covers various types and limitations of active surveillance programs, including the use of large databases and disparate data sources for rapid signal detection, as well as novel and advanced design and analysis approaches for causal interference from observational data. This book serves as an important reference for pharmacovigilance scientists and pharmacoepidemiologists who are searching for the appropriate study design to answer safety research questions. Readers will be able to effectively and efficiently design and interpret findings from post-authorization safety studies with the goal of improving the benefit-risk balance of a drug in order to optimize patient safety. Discusses all types of observational studies in post-marketing drug safety assessment, from spontaneous reporting systems, to pragmatic trials, with examples from real-world settings Presents various types of post-authorization safety studies Offers solutions to the common challenges in the design and conduct of these studies Highlights active surveillance programs, including common data models for rapid signal detection of drug safety issues

Follow on Biologics

Follow on Biologics Book
Author : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher : Unknown
Release : 2008
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Follow on Biologics book written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Vaccinology

Vaccinology Book
Author : Alan D. T. Barrett
Publisher : John Wiley & Sons
Release : 2015-02-16
ISBN : 0470656166
Language : En, Es, Fr & De

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Book Description :

Vaccinology: An Essential Guide outlines in a clear, practical format the entire vaccine development process, from conceptualization and basic immunological principles through to clinical testing and licensing of vaccines. With an outstanding introduction to the history and practice of vaccinology, it also guides the reader through the basic science relating to host immune responses to pathogens. Covering the safety, regulatory, ethical, and economic and geographical issues that drive vaccine development and trials, it also presents vaccine delivery strategies, novel vaccine platforms (including experimental vaccines and pathogens), antigen development and selection, vaccine modelling, and the development of vaccines against emerging pathogens and agents of bioterror. There are also sections devoted to veterinary vaccines and associated regulatory processes. Vaccinology: An Essential Guide is a perfect tool for designed for undergraduate and graduate microbiologists and immunologists, as well as residents, fellows and trainees of infectious disease and vaccinology. It is also suitable for all those involved in designing and conducting clinical vaccine trials, and is the ideal companion to the larger reference book Vaccinology: Principles and Practice.

Detection of New Adverse Drug Reactions

Detection of New Adverse Drug Reactions Book
Author : M. D. B. Stephens,J. C. C. Talbot,Philip Routledge
Publisher : Nature Publishing Group
Release : 1998
ISBN : 9781561591909
Language : En, Es, Fr & De

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Book Description :

This book examines the drug information cycle within pharmaceutical companies and assesses existing methods of collection, storage and processing of adverse event data and outlines ways of improving the drug information cycle. It is the only reference covering the entire field of pharmacovigilance.

Drug Safety Evaluation

Drug Safety Evaluation Book
Author : Shayne C. Gad
Publisher : Wiley-Interscience
Release : 2002-04-18
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Covers the scientific and philosophical bases for evaluation of specific concerns, such as carcinogenicity and development toxicity.

Library Information Science Abstracts

Library   Information Science Abstracts Book
Author : Anonim
Publisher : Unknown
Release : 2003
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Library Information Science Abstracts book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Veterinary Pharmacovigilance

Veterinary Pharmacovigilance Book
Author : Kevin Woodward
Publisher : John Wiley & Sons
Release : 2009-11-24
ISBN : 9781444322941
Language : En, Es, Fr & De

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Book Description :

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.

Principles of Clinical Research

Principles of Clinical Research Book
Author : Institute of Clinical Research
Publisher : Routledge
Release : 2001
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

In an arena which has seen rapid change over the past decade, this work provides a comprehensive and up-to-date guide to the planning, organization and management of clinical trials.

Reports of Cases Before the Court

Reports of Cases Before the Court Book
Author : Court of Justice of the European Communities
Publisher : Unknown
Release : 2003
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Reports of Cases Before the Court book written by Court of Justice of the European Communities, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

The Rules Governing Medicinal Products in the European Community

The Rules Governing Medicinal Products in the European Community Book
Author : Commission of the European Communities
Publisher : Bernan Press(PA)
Release : 1993
ISBN : 9789282651742
Language : En, Es, Fr & De

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Book Description :

Download The Rules Governing Medicinal Products in the European Community book written by Commission of the European Communities, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Official Journal of the European Communities

Official Journal of the European Communities Book
Author : Anonim
Publisher : Unknown
Release : 1998
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Official Journal of the European Communities book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Herbal Medicinal Products

Herbal Medicinal Products Book
Author : Frauke Gaedcke,Barbara Steinhoff,Helga Blasius
Publisher : Unknown
Release : 2003
ISBN : 9783887630980
Language : En, Es, Fr & De

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Book Description :

European legislation requires herbal medicinal products (HMPs) to meet strict standards of quality, safety and efficacy. In Europe and worldwide, HPMs play an important role both in self-medication and in medical practice. Book jacket.

The Rules Governing Medicinal Products in the European Union

The Rules Governing Medicinal Products in the European Union Book
Author : Commission of the European Communities,European Commission
Publisher : Bernan Assoc
Release : 1998
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Examine the rules governing medicinal products for use in Europe, in this five volume collection. Volume I contains rules governing medicinal products for human use; Volume II provides notice to applicants for marketing authorizations and includes 2 disks; Volume III presents guidelines on quality, safety, and efficacy of medicinal products for human use; Volume IV is a guide to good manufacturing practices for medicinal products for human and veterinary use; Volume V contains rules governing medicinal products for veterinary use.

Statutory Instruments

Statutory Instruments Book
Author : Anonim
Publisher : Unknown
Release : 2008
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Statutory Instruments book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Product Defects and Hazards

Product Defects and Hazards Book
Author : James T. O'Reilly
Publisher : John Wiley & Sons
Release : 1987
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

This volume ties in civil liability's reach into design and warnings, and contrasts those defects with each of the product categories in which governmental regulatory agencies make thier defect decisions.

Dictionary of Pharmacovigilance

Dictionary of Pharmacovigilance Book
Author : Amer Alghabban
Publisher : Unknown
Release : 2004
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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.

The Rules Governing Medicinal Products in the European Union

The Rules Governing Medicinal Products in the European Union Book
Author : Commission of the European Communities
Publisher : Unknown
Release : 1995
ISBN : 9789282692073
Language : En, Es, Fr & De

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Book Description :

Download The Rules Governing Medicinal Products in the European Union book written by Commission of the European Communities, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Federal Food Drug and Cosmetic Act

Federal Food  Drug  and Cosmetic Act Book
Author : Vincent A. Kleinfeld,Alan H. Kaplan
Publisher : Unknown
Release : 1983
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Federal Food Drug and Cosmetic Act book written by Vincent A. Kleinfeld,Alan H. Kaplan, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Antimicrobial Resistance

Antimicrobial Resistance Book
Author : International Office of Epizootics
Publisher : OIE
Release : 2001
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Antimicrobial Resistance book written by International Office of Epizootics, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.