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Benefit-risk Assessment (benefit-risk + assessment)

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Medical Sciences100%

Selected Abstracts

Retracted: A quantitative approach to benefit-risk assessment of medicines,part 2; the practical application of a new model Filip Mussen, Sam Salek, Stuart Walker

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 10 2007
Ronald D. Mann Editor-in-Cheif
The following article from Pharmacoepidemiology and Drug Safety, ,A Quantitative Approach to Benefit-Risk Assessment of Medicines,Part 2; The Practical Application of a New Model' by Mussen F, Salek S & Walker S (Pharmacoepidemiol Drug Saf 2007; 16: S16,S41 DOI: 10.1002/pds.1434) has been retracted by agreement between the authors, the Journal's Editor-in-Chief and John Wiley & Sons, Ltd. The retraction has been agreed due to overlap between this article and an internal report published by CMR International Institute; ,Benefit-Risk Assessment Model Developing a Structured Approach to Decision Making'. [source]

Retracted:A quantitative approach to benefit-risk assessment of medicines , part 2: the practical application of a new model,

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue S1 2007
Filip Mussen PhD
Purpose Retraction: The following article from Pharmacoepidemiology and Drug Safety, A Quantitative Approach to Benefit-Risk Assessment of Medicines - Part 2; The Practical Application of a New Model by Mussen F, Salek S & Walker S (Pharmacoepidemiol Drug Saf 2007;16:S16-S41 DOI:10.1002/pds.1434) has been retracted by agreement between the authors, the Journal Editor-in-Chief and John Wiley & Sons, Ltd. The retraction has been agreed due to overlap between this article and an internal report published by CMR International Institute; Benefit-Risk Assessment Model Developing a Structured Approach to Decision Making. [source]

Probiotics: Immunomodulation and Evaluation of Safety and Efficacy

NUTRITION REVIEWS, Issue 1 2006
Janine Ezendam PhD
The intake of probiotics has been associated with beneficial effects on the immune system, such as improved disease resistance and diminished risk of allergies. This review gives an overview of the immunomodulatory effects of probiotics investigated with in vitro assays, experimental animal models, and clinical trials, and explores possible mechanisms underlying the immunomodulatory effects. Immunomodulation, however, is not always beneficial and might induce detrimental effects; therefore, a scheme is proposed for benefit-risk assessment of immunomodulation by probiotics. Within this scheme, expert judgment based on data derived from a panel of in vitro assays, animal models, and clinical trials should lead to conclusions on efficacy and safety aspects of probiotics. [source]

Retracted: A quantitative approach to benefit-risk assessment of medicines,part 2; the practical application of a new model Filip Mussen, Sam Salek, Stuart Walker

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 10 2007
Ronald D. Mann Editor-in-Cheif
The following article from Pharmacoepidemiology and Drug Safety, ,A Quantitative Approach to Benefit-Risk Assessment of Medicines,Part 2; The Practical Application of a New Model' by Mussen F, Salek S & Walker S (Pharmacoepidemiol Drug Saf 2007; 16: S16,S41 DOI: 10.1002/pds.1434) has been retracted by agreement between the authors, the Journal's Editor-in-Chief and John Wiley & Sons, Ltd. The retraction has been agreed due to overlap between this article and an internal report published by CMR International Institute; ,Benefit-Risk Assessment Model Developing a Structured Approach to Decision Making'. [source]

A quantitative approach to benefit-risk assessment of medicines , part 1: the development of a new model using multi-criteria decision analysis,

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue S1 2007
Filip Mussen PhD
Abstract Purpose One of the most important uses of benefit-risk assessment pertains to approval of new medicines by regulatory authorities and the subsequent review of these products during their life-cycle when new safety and/or efficacy data becomes available. At present, there exist no validated, well-accepted models for benefit-risk assessment that have the appropriate degree of sophistication, and as a consequence no models are widely used by regulatory authorities or industry. The aim of the study was therefore to develop a new model for benefit-risk assessment of medicines using multi-criteria decision analysis (MCDA). Methods The MCDA methodology was used for a systematic approach to assess the benefit risk ratio of medicines. The reasons for adopting this approach were (1) taking multiple benefit and risk criteria into account, (2) making a judgement on the evidence and potential uncertainty because of the incompleteness of evidence, and (3) making trade-offs of the benefits against risks. Results It was demonstrated through a seven-step approach how MCDA is used to construct the model. Ten benefit and ten risk criteria were identified to form a value tree. Then fixed scales were established for all criteria and options on the criteria were scored. Weights were assigned for each criteria using swing-weighting. Finally sensitivity analysis was carried. Conclusions This novel approach based on MCDA has the potential for being applied as a new tool for judging and deciding on the benefits and risks, thereby helping regulators and industry in the development and approval of new medicines and their adequate use. Copyright © 2007 John Wiley & Sons, Ltd. [source]

Retracted:A quantitative approach to benefit-risk assessment of medicines , part 2: the practical application of a new model,

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue S1 2007
Filip Mussen PhD
Purpose Retraction: The following article from Pharmacoepidemiology and Drug Safety, A Quantitative Approach to Benefit-Risk Assessment of Medicines - Part 2; The Practical Application of a New Model by Mussen F, Salek S & Walker S (Pharmacoepidemiol Drug Saf 2007;16:S16-S41 DOI:10.1002/pds.1434) has been retracted by agreement between the authors, the Journal Editor-in-Chief and John Wiley & Sons, Ltd. The retraction has been agreed due to overlap between this article and an internal report published by CMR International Institute; Benefit-Risk Assessment Model Developing a Structured Approach to Decision Making. [source]

Adverse drug reactions and off-label prescribing for paediatric outpatients: a one-year survey of spontaneous reports in Sweden

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 3 2004
Mike Ufer MD
Abstract Purpose To investigate the extent and characteristics of off-label prescribing for paediatric outpatients among drugs reported to have caused an adverse reaction. Methods A retrospective, cross-sectional, observational analysis of spontaneous adverse drug reaction (ADR) reports in Sweden in the year 2000. We included all reports concerning drugs prescribed for outpatients younger than 16 years. Each ADR was classified with respect to its causality, seriousness and type of reaction. Off-label prescribing was evaluated with respect to age, dose, indication, formulation and route and frequency of administration. Results We identified 112 patient-linked reports corresponding to 158 ADRs of which 31% were serious. Antiasthmatic drugs were most frequently suspected as a cause of almost every third adverse reaction. The average proportion of off-label drug prescribing amounted to 42.4%. It was more frequently associated with serious than non-serious ADRs and mostly due to a non-approved age or dose. The most common clinical manifestations were psychiatric disorders and mucocutaneous inflammatory reactions. Conclusions Off-label prescribing for paediatric outpatients is common among drugs reported to have caused an ADR. It is suggested to further identify unlabelled drugs frequently contributing to, in particular serious ADRs in children for a proper benefit-risk assessment of off-label drug use. Copyright © 2003 John Wiley & Sons, Ltd. [source]