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This book serves as a roadmap for the development and application of patient-reported outcome (PRO) measures, supporting beginners through to experts, as a practical guide. To elucidate on key concepts in the book, examples from clinical research in hyperhidrosis and...
This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified,...
This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox.Over the past decade, pharmaceutical companies and regulatory agencies...
Benefit-risk assessment is at the centre of the approval process for every new medicine. The ability to assess the risks of a new medicine accurately and to balance these against the benefits the medicine could bring is critical for every regulatory authority and...
Offers a social view of the activities leading to the timely patient access to medicines including: drug research, drug production, drug distribution, drug prescribing, drug information and drug control Provides theoretical models to enable pharmacists to understand...
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