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体现可接受性证据:儿科制剂开发的“两难困境”。

Demonstrating evidence of acceptability: the "catch-22" of pediatric formulation development.

机构信息

Department of Pharmaceutics and Centre for Paediatric Pharmacy Research, UCL School of Pharmacy, London, UK.

出版信息

Clin Pharmacol Ther. 2013 Nov;94(5):582-4. doi: 10.1038/clpt.2013.154. Epub 2013 Jul 26.

Abstract

Both researchers and practitioners have reached an influential period in the new era of developing pediatric medicines. Evolving regulatory reforms and guidance continue to serve as platforms steering research and development while distinctive opportunities and challenges in the field emerge. An advancing research need involves gaining a better understanding of end-user requirements and acceptability of formulations. This review considers solid oral forms to demonstrate the importance of such research to stakeholders in policy and practice.

摘要

研究人员和从业者都已经进入了儿科药物发展的新时代的一个重要时期。不断发展的监管改革和指导意见继续为研究和开发提供平台,同时该领域也出现了独特的机遇和挑战。其中一个推进的研究需求是更好地了解最终用户对制剂的需求和可接受性。本文回顾了固体制剂,以证明这种研究对政策制定者和实践者相关利益方的重要性。

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