Product Description: This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development...read more

Product Description: A range of factors must be considered when developing a topical antimicrobial for use in a healthcare personnel handwash, surgical scrub, or preoperative skin preparation. Antimicrobial effectiveness, low skin irritation, ease of use, and pleasing aesthetics are all essential if the product is to succeed...read more

“The challenge in all settings is to make the difficult decisions in a way that is defensible, justifiable, ethical, and equitable” So write Nick Freemantle and Suzanne Hill in their introduction to this important discussion on decision making in the reimbursement of pharmaceuticals. Based around a programme supported by the World Health Organization, chapters by leading academics involved in the research tackle such major issues as international pharmaceutical policy, tensions in licensing policies, priority setting, and relationships between the stakeholders. Chapters includeDevelopment of marketing authorisation procedures for pharmaceuticalsInterpreting clinical evidenceInternational pharmaceutical policy: health creation or wealth creation?Development of fourth hurdle policies around the worldEconomic modelling in drug reimbursementPriority setting in health care: matching decision criteria with policy objectivesTensions in licensing and reimbursement decisions: case of riluzole for amytrophic lateral sclerosisRelationship between stakeholders: managing the war of wordsMedicine and the media: good information or misleading hype?How to promote quality use of cost-effective medicines Using economic evaluation to inform health policy and reimbursement: making it happen and making it sustainablePricing of pharmaceuticalsEvaluating pharmaceuticals for health policy in low and middle income country settings. Besides the controversial issues there is a wealth of practical information including economic modelling and the experiences from the WHO programme, providing readers with workable examples. This is essential reading for clinical researchers in pharmaceuticals and policy makers everywhere.

Product Description: Imparts a working understanding of the statistical principles and procedures essential to conducting successful clinical studies. Features a detailed catalog of experimental designs most commonly used in clinical work. Includes two chapters on elementary applied statistics and one on sample size estimation (the number of patients required)...read more

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