Pre-fillable Syringes for the Biotechnological Requirements of the Present and Future

Jul 22, 2016

Pre-fillable syringes are both pharmaceutical primary packaging and drug delivery devices. End users, drug administration agencies and the pharmaceutical industry are imposing increasingly stringent quality requirements on pre-fillable syringes in both these functions. Optimised production and inspection processes ensure that the syringes can meet these requirements. Although siliconisation is crucial as lubricant to the proper function of the plunger in the syringe body, it has to be reduced to the minimum in syringes used for innovative biotech drugs. Bernd ZeiƟ and Claudia Petersen at Gerresheimer look into the world of pre-fillable syringes. ...

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Innovations in the PASS Concept

Jul 22, 2016

Opening the Door to Real-world Data The role of data collected during post-marketing surveillance has recently been widely recognised as being of great value in terms of providing real-world evidences, as long as the credibility, quality and transparency of data is maintained. In parallel with the dynamic increase of requirements and challenges concerning Post- Authorisation Safety Studies planning, conduct and assessment, the European Medicines Agency offers flexibility and firm scientific assistance to marketing authorisation holders. Magdalena Matusiak, MPharm, Clinical Development Manager at KCR, focuses on the PASS concept. ...

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Regulatory Focus on Nanomedicines in US and Europe

Jul 22, 2016

This article aims to produce an overview of nanotechnology and its drug delivery systems, as well as the regulatory approach for the approval of nanomedicines in regulated markets like the United States and Europe. The use of nanoscale technologies to design novel drug delivery systems and devices is a rapidly developing area that promises breakthrough advances in therapeutics and diagnostics. Nanomedicine is one area of nanotechnology, and the goal of nanomedicine is to provide the most effective treatment without side-effects. Vidhya Sabbella, Valluru Ravi, Prof. T. M. Pramod Kumar and Sreekanth Reddy Kaja at JSS College submit a new white ...

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