Therapeutic Risk Management of Medicines

Written By Stephen J. Mayall
Therapeutic Risk Management of Medicines
  • Publsiher : Elsevier
  • Release : 16 April 2014
  • ISBN : 1908818271
  • Pages : 448 pages
  • Rating : 4/5 from 21 reviews
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Read or download book entitled Therapeutic Risk Management of Medicines written by Stephen J. Mayall which was release on 16 April 2014, this book published by Elsevier. Available in PDF, EPUB and Kindle Format. Book excerpt: Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities, and interact effectively with key stakeholders. A more systematic approach for managing the risks of medicines arose following a number of high-profile drug safety incidents and a need for better access to effective but potentially risky treatments. Regulatory requirements have evolved rapidly over the past decade. Risk management plans (RMPs) are mandatory for new medicinal products in the EU and a Risk Evaluation and Mitigation Strategy (REMS) is needed for certain drugs in the US. This book is an easy-to-read resource that complements current regulatory guidance, by exploring key areas and practical implications in greater detail. It is structured into chapters encompassing a background to therapeutic risk management, strategies for developing RMPs, implementation of RMPs, and the continuing evolution of the risk management field.The topic is of critical importance not only to the pharmaceutical and biotechnology industries, but also regulators and healthcare policymakers.Some chapters feature contributions from selected industry experts. An up-to-date practical guide on conceiving, designing, and implementing global therapeutic risk management plans for medicines A number of useful frameworks are presented which add impact to RMPs (Risk Management Plans), together with regional specific information (European Union, United States, and Japan) A comprehensive guide for performing risk management more effectively throughout a product’s life-cycle

Therapeutic Risk Management of Medicines

Therapeutic Risk Management of Medicines
  • Author : Stephen J. Mayall,Anjan Swapu Banerjee
  • Publisher : Elsevier
  • Release Date : 2014-04-16
  • Total pages : 448
  • ISBN : 1908818271
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Summary : Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities, and interact effectively with key stakeholders. A more systematic approach ...

Therapeutic Risk

Therapeutic Risk
  • Author : William Howard Wallace Inman,D. M. Burley
  • Publisher : John Wiley & Sons
  • Release Date : 1988
  • Total pages : 103
  • ISBN : 1908818271
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Summary : Today's therapeutic drugs are capable of beneficial results but can also cause great harm, especially if administered to the wrong patient in the wrong dosage. This book is devoted to the perception, measurement and management of therapeutic risk, and outlines the results of a conference on the subject held in ...

The Perception and Management of Therapeutic Risk

The Perception and Management of Therapeutic Risk
  • Author : Paul Slovic,Centre for Medicines Research
  • Publisher : Unknown
  • Release Date : 1989
  • Total pages : 32
  • ISBN : 1908818271
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Summary : Download or read online The Perception and Management of Therapeutic Risk written by Paul Slovic,Centre for Medicines Research, published by which was released on 1989. Get The Perception and Management of Therapeutic Risk Books now! Available in PDF, ePub and Kindle....

Therapeutic Protein Drug Products

Therapeutic Protein Drug Products
  • Author : Brian K Meyer
  • Publisher : Elsevier
  • Release Date : 2012-01-02
  • Total pages : 200
  • ISBN : 1908818271
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Summary : Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, ...

Communicating about Risks and Safe Use of Medicines

Communicating about Risks and Safe Use of Medicines
  • Author : Priya Bahri
  • Publisher : Springer Nature
  • Release Date : 2020-06-17
  • Total pages : 504
  • ISBN : 1908818271
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Summary : At the core of this book lies the question how to approach medicines, risks and communication as a researcher - or anybody planning and evaluating a communication intervention, or wanting to understand communication events in private and the media. With a view to tackle current shortcomings of communication systems and ...

Human Drug Metabolism

Human Drug Metabolism
  • Author : Michael D. Coleman
  • Publisher : John Wiley & Sons
  • Release Date : 2020-02-19
  • Total pages : 680
  • ISBN : 1908818271
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Summary : Provides a timely update to a key textbook on human drug metabolism The third edition of this comprehensive book covers basic concepts of teaching drug metabolism, starting from extreme clinical consequences to systems and mechanisms and toxicity. It provides an invaluable introduction to the core areas of pharmacology and examines ...

Therapeutic Antibody Engineering

Therapeutic Antibody Engineering
  • Author : William R Strohl,Lila M Strohl
  • Publisher : Elsevier
  • Release Date : 2012-10-16
  • Total pages : 696
  • ISBN : 1908818271
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Summary : The field of antibody engineering has become a vital and integral part of making new, improved next generation therapeutic monoclonal antibodies, of which there are currently more than 300 in clinical trials across several therapeutic areas. Therapeutic antibody engineering examines all aspects of engineering monoclonal antibodies and analyses the effect that ...

Gene therapy

Gene therapy
  • Author : Surendra Nimesh
  • Publisher : Elsevier
  • Release Date : 2013-10-31
  • Total pages : 380
  • ISBN : 1908818271
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Summary : Gene therapy is emerging as a new class of therapeutics for the treatment of inherited and acquired diseases. However, poor cellular uptake and instability of DNA in the physiological milieu limits its therapeutic potential, hence a vector which can protect and efficiently transport DNA to the target cells must be ...

The Pharmacist at the Crossroads of New Health Risks an Indispensable Partner for Their Management

The Pharmacist at the Crossroads of New Health Risks   an Indispensable Partner for Their Management
  • Author : Council of Europe
  • Publisher : Council of Europe
  • Release Date : 2000-01-01
  • Total pages : 222
  • ISBN : 1908818271
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Summary : This publication contains the speeches and conclusions of a seminar held in October 1999, which looked at the role of the pharmacist as a co-guarantor of health security. The first theme was health challenges of the 21st Century, which included the safety of new therapies, the pharmacists role in risk management ...

Guidelines for Off Label Drugs Concept and Good Clinical Practice

Guidelines for Off Label Drugs   Concept and Good Clinical Practice
  • Author : Ph. Malik Qasem Ozaybi
  • Publisher : Ph. Malik Qasem Ozaybi
  • Release Date : 2021-05-12
  • Total pages : 134
  • ISBN : 1908818271
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Summary : This edition of the book encompasses the off label(unapproved) indications and uses of 191 drugs with last update also comparison with FDA approved indications. Also give you Information about research and how to make an excellent research with discussion and compare between primary studies and secondary studies with advantages and ...

Risk Management ISO 14971

Risk Management  ISO 14971
  • Author : Beverly White
  • Publisher : Unknown
  • Release Date : 2021-12-19
  • Total pages : 89
  • ISBN : 1908818271
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Summary : Comprehensive yet concise reference edition to assist in the application of Risk management for medical devices. ISO 14971, is an established standard that is recognized worldwide by regulators. It is acknowledged as being the principal standard to use when performing Medical Device Risk Management. PART 1: RISK MANAGEMENT Introduction Basic terms and ...

Nanoparticulate Drug Delivery

Nanoparticulate Drug Delivery
  • Author : Vandana Patravale,Prajakta Dandekar,Ratnesh Jain
  • Publisher : Elsevier
  • Release Date : 2012-10-31
  • Total pages : 244
  • ISBN : 1908818271
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Summary : Nanotechnology-based therapeutics, operating at scales of billionths of a metre, have great potential for future expansion in altering the scale and methods of drug delivery. The availability of these novel formulations to once-inaccessible areas of the body has greatly expanded the therapeutic window of existing drug molecules. Nanoparticulate drug delivery ...

Sterility Sterilisation and Sterility Assurance for Pharmaceuticals

Sterility  Sterilisation and Sterility Assurance for Pharmaceuticals
  • Author : Tim Sandle
  • Publisher : Elsevier
  • Release Date : 2013-10-31
  • Total pages : 362
  • ISBN : 1908818271
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Summary : Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for ...

Formulation tools for Pharmaceutical Development

Formulation tools for Pharmaceutical Development
  • Author : J E Aguilar
  • Publisher : Elsevier
  • Release Date : 2013-09-30
  • Total pages : 304
  • ISBN : 1908818271
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Summary : A range of new and innovative tools used for preformulation and formulation of medicines help optimize pharmaceutical development projects. Such tools also assist with the performance evaluation of the pharmaceutical process, allowing any potential gaps to be identified. These tools can be applied in both basic research and industrial environment. ...

Computer Aided Applications in Pharmaceutical Technology

Computer Aided Applications in Pharmaceutical Technology
  • Author : Jelena Djuris
  • Publisher : Elsevier
  • Release Date : 2013-04-10
  • Total pages : 300
  • ISBN : 1908818271
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Summary : Research and development in the pharmaceutical industry is a time-consuming and expensive process, making it difficult for newly developed drugs to be formulated into commercially available products. Both formulation and process development can be optimized by means of statistically organized experiments, artificial intelligence and other computational methods. Simultaneous development and ...