Therapeutic Risk Management of Medicines

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  • Publisher : Elsevier
  • Release : 16 April 2014
  • ISBN : 9781908818270
  • Page : 448 pages
  • Rating : 4.5/5 from 103 voters

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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

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Therapeutic Risk Management of Medicines

Therapeutic Risk Management of Medicines
  • Author : Stephen J. Mayall,Anjan Swapu Banerjee
  • Publisher : Elsevier
  • Release Date : 2014-04-16
  • ISBN : 9781908818270
GET THIS BOOKTherapeutic Risk Management of Medicines

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

Pharmacoepidemiology and Therapeutic Risk Management

Pharmacoepidemiology and Therapeutic Risk Management
  • Author : Abraham G. Hartzema
  • Publisher : Harvey Whitney Books
  • Release Date : 2008-01-01
  • ISBN : 0929375300
GET THIS BOOKPharmacoepidemiology and Therapeutic Risk Management

Smart Health Choices

Smart Health Choices
  • Author : Les Irwig
  • Publisher : Judy Irwig
  • Release Date : 2007-09
  • ISBN : 9781905140176
GET THIS BOOKSmart Health Choices

This book aims to help consumers and practitioners develop the skills to assess health advice - and hopefully to make decisions that will improve the quality of their care. For some people, making better-informed decisions could be life saving. We hope that it will be useful if you are struggling to come to terms with an illness or injury, and the best ways of managing it. Or you may simply want to lead a healthier life, and may be wondering

Therapeutic Risk

Therapeutic Risk
  • Author : William Howard Wallace Inman,D. M. Burley
  • Publisher : John Wiley & Sons
  • Release Date : 1988
  • ISBN : UOM:39015014491685
GET THIS BOOKTherapeutic Risk

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 Brighton, Sussex in June 1987 - a joint enterprise between the Trust for Education and Research in Therapeutics, London, and the Drug Safety Research Trust, Southampton. It examines the results of

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
  • ISBN : OCLC:22880142
GET THIS BOOKThe Perception and Management of Therapeutic Risk

Therapeutic Protein Drug Products

Therapeutic Protein Drug Products
  • Author : Brian K Meyer
  • Publisher : Elsevier
  • Release Date : 2012-01-02
  • ISBN : 9781908818102
GET THIS BOOKTherapeutic Protein Drug Products

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, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches.

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
  • ISBN : 9789811530135
GET THIS BOOKCommunicating about Risks and Safe Use of Medicines

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 processes for improved implementation, patient satisfaction and health outcomes, a multilayered approach is presented. This combines multiple data types and methods to obtain a wider and deeper understanding of the

Human Drug Metabolism

Human Drug Metabolism
  • Author : Michael D. Coleman
  • Publisher : John Wiley & Sons
  • Release Date : 2020-02-19
  • ISBN : 9781119458562
GET THIS BOOKHuman Drug Metabolism

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 recent progress and advances in this fast moving field and its clinical impact. Human Drug Metabolism, 3rd Edition begins by covering basic concepts such as clearance and bioavailability, and looks

Therapeutic Antibody Engineering

Therapeutic Antibody Engineering
  • Author : William R Strohl,Lila M Strohl
  • Publisher : Elsevier
  • Release Date : 2012-10-16
  • ISBN : 9781908818096
GET THIS BOOKTherapeutic Antibody Engineering

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 various genetic engineering approaches will have on future candidates. Chapters in the first part of the book provide an introduction to monoclonal antibodies, their discovery and development and the fundamental

Gene therapy

Gene therapy
  • Author : Surendra Nimesh
  • Publisher : Elsevier
  • Release Date : 2013-10-31
  • ISBN : 9781908818645
GET THIS BOOKGene therapy

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 developed. Nanotechnology-based non-viral vectors have been proposed as potential candidates. Various polymeric nanoparticles have been shown to be suitable, with high cellular uptake efficiencies and reduced cytotoxicity. These delivery vectors

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
  • ISBN : 9287144044
GET THIS BOOKThe Pharmacist at the Crossroads of New Health Risks - an Indispensable Partner for Their Management

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 and the problems of the counterfeiting of drugs. The second theme concerned the challenges of the new technologies both the dangers of selling drugs over the internet and the opportunities

Nanoparticulate Drug Delivery

Nanoparticulate Drug Delivery
  • Author : Vandana Patravale,Prajakta Dandekar,Ratnesh Jain
  • Publisher : Elsevier
  • Release Date : 2012-10-31
  • ISBN : 9781908818195
GET THIS BOOKNanoparticulate Drug Delivery

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 highlights and examines the transition of nanoparticulate drug delivery systems from the laboratory into a commercially viable sector. The first chapters of the book provide an overview of the use

Transporters in Drug Discovery and Development

Transporters in Drug Discovery and Development
  • Author : Yurong Lai
  • Publisher : Woodhead Publishing
  • Release Date : 2014-08-22
  • ISBN : 9781908818287
GET THIS BOOKTransporters in Drug Discovery and Development

Written by a leading researcher in the field, Transporters in Drug Discovery and Development provides a comprehensive and practical guide to drug transporter families that are the most important for drug discovery and development. It covers: an overview of transporter families and organ distribution; clinical relevant drug-drug interaction; clinical relevant polymorphism; drug transporter related pharmacokinetic, pharmacodynamics and toxicity; in vitro/in vivo probes of drug transport studies; the practical methodologies of industrial transporter screening and translational aspect in drug discovery

Formulation tools for Pharmaceutical Development

Formulation tools for Pharmaceutical Development
  • Author : J E Aguilar
  • Publisher : Elsevier
  • Release Date : 2013-09-30
  • ISBN : 9781908818508
GET THIS BOOKFormulation tools for Pharmaceutical Development

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. Formulation tools for pharmaceutical development considers these key research and industrial tools. Nine chapters by leading contributors cover: Artificial neural networks technology to model, understand, and optimize drug formulations; ME_

Computer-Aided Applications in Pharmaceutical Technology

Computer-Aided Applications in Pharmaceutical Technology
  • Author : Jelena Djuris
  • Publisher : Elsevier
  • Release Date : 2013-04-10
  • ISBN : 9781908818324
GET THIS BOOKComputer-Aided Applications in Pharmaceutical Technology

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 investigation of pharmaceutical products and processes enables application of quality by design concept that is being promoted by the regulatory authorities worldwide. Computer-aided applications in pharmaceutical technology covers the fundamentals