Effective complaint handling, investigations and adverse event reporting
September 1st 2008The challenges of ineffective quality monitoring of complaints, investigations and adverse event reporting can lead to patient harm or death, product withdrawal, and negative financial and brand impact to the organization.
Pseudo-polymorphic conversion by near-infrared spectroscopy
September 1st 2008Near-infrared spectroscopy (NIR) is suitable for the analysis of pharmaceutical samples in various solid forms, and can be used for determining chemical properties (e.g., content of drug, water), as well as physical properties (e.g., particle size, tablet hardness).
Bioanalysis of recombinant proteins by mass spectrometry
September 1st 2008Biotechnological developments have led to an increased number of recombinant proteins or antibodies in drug development that offer high potential in various diseases, such as cancer, growth disturbances and diabetes.