Filip Mussen's Benefit-Risk Appraisal of Medicines: A systematic approach PDF

By Filip Mussen

ISBN-10: 0470060859

ISBN-13: 9780470060858

Benefit-risk evaluate is on the centre of the approval approach for each new drugs. the facility to evaluate the hazards of a brand new medication adequately and to stability those opposed to the advantages the medication may deliver is important for each regulatory authority and pharmaceutical corporation. regardless of this there are only a few attempted and proven evaluative versions presently available.The authors of this ebook have constructed a brand new, pioneering device for the evaluation of advantages and hazards for brand spanking new drugs in improvement. This version utilises a multi-criteria selection research which consists of opting for, scoring and weighting key gain and hazard attributes and ends up in an total appraisal of advantages and hazards of medicines.Benefit-Risk Appraisal of medications establishes the historical past and standards required to evaluate profit and chance regularly and reports the present practices through regulatory experts and the pharmaceutical undefined, together with these types at the moment on hand. It outlines the advance and overview of the authors’ new version and analyses the consequences of its implementation.Describes an leading edge, systematic version which ends up in obvious and dependable benefit-risk selection makingContributes very important principles to the talk on benefit-risk appraisalProvides a destiny framework for benefit-risk appraisal of medicinesBenefit-Risk Appraisal of medications covers the total procedure from the invention of latest drugs to their advertising and is perfect for all those that paintings within the pharmaceutical and regulatory authorities,, in addition to post-graduate scholars of pharmaceutical medication and scientific pharmacology.

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Additional info for Benefit-Risk Appraisal of Medicines: A systematic approach to decision-making

Example text

Safety criterion no. g. safety criterion no. 20 – adverse events). Therefore, in the next section a systematic review will be conducted to identify and define the relevant criteria based on the above list and based on additional literature references. 1 The benefit and risk criteria required to be covered in the Common Technical Document (‘ICH’), in the EU assessment reports (‘EU’), and in US Medical Reviews (‘FDA’) Efficacya 1. Relevant features of the patient populations, including demographic features, disease stage and other potential important covariates, any important patient populations excluded from critical studies, participation of children and elderly and the population that would be expected to receive the medicine after marketing 2.

Conclusions on the existing models Based on this review of the literature, it is apparent that there are relatively few general methods and models for benefit–risk assessment, in particular for use by regulatory authorities. None of these methods seem to be widely accepted and applied. In general, there appears to be a lack of a methodological framework and guidance with regard to the relevant benefit and risk criteria to be considered for benefit–risk assessments, and with regard to trading-off the benefits and risks of medicines.

The goal is to find a dose that satisfies both safety and efficacy requirements. A simple method to obtain trade-off information is to specify, a priori, the maximum toxicity rate that would be acceptable if the new treatment were to produce 100% response, and similarly to specify a minimum response rate that would be acceptable if the treatment produced no toxicities (Conaway and Petroni, 1996). This method, in which the efficacy–toxicity requirements are specified, against which the medicines are then compared, can be applied to dose-finding studies and for other phase I and phase II trials.

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Benefit-Risk Appraisal of Medicines: A systematic approach to decision-making by Filip Mussen


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