Therapeutic 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 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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  • Author : Stephen J. Mayall
  • Publisher : Elsevier
  • Pages : 448 pages
  • ISBN : 1908818271
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKTherapeutic Risk Management of Medicines

Therapeutic Risk Management of Medicines

Therapeutic Risk Management of Medicines
  • Author : Stephen J. Mayall,Anjan Swapu Banerjee
  • Publisher : Elsevier
  • Release : 16 April 2014
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

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  • Publisher : John Wiley & Sons
  • Release : 19 October 1988
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

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  • Publisher : John Wiley & Sons
  • Release : 19 February 2020
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

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  • Author : Brian K Meyer
  • Publisher : Elsevier
  • Release : 02 January 2012
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.

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  • Publisher : Elsevier
  • Release : 31 October 2013
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

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  • Publisher : Universal-Publishers
  • Release : 19 October 2021
GET THIS BOOKThe Role of the Pharmacist in Patient Care

The goal of a high quality, cost-effective and accessible health care for patients is achieved through constructing a team-based and patient-centered health care delivery system. The expanded role of pharmacists uplifts them to patient care from dispensing and manufacturing or marketing of drugs. Along with doctors and allied health professionals, pharmacists are increasingly recognized as an integral part of the patient care team. Furthermore, colleges of pharmacy need to revise and up-date their curricula to accommodate the progressively increasing development

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  • Author : Sabrina Nour,Gilles Plourde
  • Publisher : Academic Press
  • Release : 17 October 2018
GET THIS BOOKPharmacoepidemiology and Pharmacovigilance

Pharmacoepidemiology and Pharmacovigilance: Synergistic Tools to Better Investigate Drug Safety examines the role of pharmacoepidemiologic studies in drug development and its use as a prevention tool in pharmacovigilance activities. The book introduces the various epidemiologic tools and study designs commonly used for the surveillance of drug-related adverse effects and reviews the strengths and weaknesses of each. Criticisms surrounding pharmacoepidemiologic research and issues that often interfere or complicate the conduct and interpretation of these studies are also explored. Case studies illustrate

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  • Author : Les Irwig
  • Publisher : Judy Irwig
  • Release : 01 September 2007
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

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  • Author : World Health Organization
  • Publisher : Unknown Publisher
  • Release : 02 March 2015
GET THIS BOOKPractical Approaches to Risk Minimisation for Medicinal Products

Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at large. Previous reports from CIOMS I - VIII provided practical guidance in some essential components of risk management such as terminology and reporting of adverse drug reactions, management of safety information from clinical trials, and safety signal detection. Beyond the detection, identification, and characterization of

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  • Publisher : Elsevier
  • Release : 31 October 2012
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

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  • Author : Yurong Lai
  • Publisher : Woodhead Publishing
  • Release : 22 August 2014
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

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  • Publisher : Elsevier
  • Release : 26 March 2013
GET THIS BOOKBacterial Cellular Metabolic Systems

The metabolic regulation of a cell system is of critical importance in systems biology, and a robust model of these mechanisms is essential in predicting the effects on the metabolism of both the culture environment and the knockout of specific genes. Bacterial cellular metabolic systems focuses on this highly topical subject in relation to culture environment and provides a detailed analysis from gene level to metabolic level regulation, as well as offering a discussion of the most recent modelling approaches.