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20 May 2005 | By Ali Afnan, Ph.D., Process Analytical Technologist, FDA/CDER/OPS
The pharmaceutical industry plays a major role in the lives of individuals by providing critical therapeutic medicines. This places the industry in the public eye, as does drug pricing, safety and efficacy, the stock markets and courting with several different regulatory bodies, with differing legal requirements, around the world. The…
7 March 2005 | By Jukka Rantanen, Senior Research Scientist, Viikki Drug Discovery Technology Centre, University of Helsinki
There is an increasing demand for new approaches to understand the chemical and physical phenomena that occur during pharmaceutical unit operations. Obtaining real-time information from processes opens new perspectives for safer manufacture of pharmaceuticals. Raman spectroscopy provides a molecular level insight into processing and it is therefore a promising process…
7 March 2005 | By Dirk C. Hinz, Ph.D., Schering AG, Corporate CMC Development, In-Process Control Dept.
Pharmaceutical manufacturing occurs in a highly regulated environment, where most of the manufacturing is performed in batches, in stop-and-go steps and with off-line testing of product quality. Additionally, due to patent restrictions, there is always ‘speed to market’ pressure.
