作者
Buket Aksu, Thomas De Beer, Staffan Folestad, Jarkko Ketolainen, Hans Lindén, Joao Almeida Lopes, Marcel de Matas, Wim Oostra, Jukka Rantanen, Marco Weimer
发表日期
2012/9/29
期刊
European Journal of Pharmaceutical Sciences
卷号
47
期号
2
页码范围
402-405
出版商
Elsevier
简介
Substantial changes in Pharmaceutical R&D strategy are required to address existing issues of low productivity, imminent patent expirations and pressures on pricing. Moves towards personalized healthcare and increasing diversity in the nature of portfolios including the rise of biopharmaceuticals however have the potential to provide considerable challenges to the establishment of cost effective and robust supply chains. To guarantee product quality and surety of supply for essential medicines it is necessary that manufacturing science keeps pace with advances in pharmaceutical R&D. In this position paper, the EUFEPS QbD and PAT Sciences network make recommendations that European industry, academia and health agencies focus attention on delivering step changes in science and technology in a number of key themes. These subject areas, all underpinned by the sciences allied to QbD and PAT, include …
学术搜索中的文章
B Aksu, T De Beer, S Folestad, J Ketolainen, H Lindén… - European Journal of Pharmaceutical Sciences, 2012