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23 November 2009
If your company is fortunate enough to have multiple projects in your development pipeline, and assuming that you do not have an unlimited resource pool, then you will be faced with some critical choices as to which projects to support and which projects not to support. Support of a project ...
29 October 2009
The ICH Harmonised Tripartite Guideline for Good Clinical Practice E6(R1), to give it its full name, was adopted in Europe in 1996 (and in the US and Japan the following year). The aim of ICH-GCP is to provide a unified standard for the EU, the US and Japan to facilitate the mutual acceptance of ...
14 October 2009
Chronic obstructive pulmonary disease (COPD) is an umbrella term that refers to chronic lung diseases that share the common feature of restricted airflow. According to the most recent estimates from the WHO, there are currently 210 million COPD patients worldwide, of whom 80 million have moderate ...
14 October 2009
Safety concerns are never far from view where pharmaceutical R&D is concerned. Early pre-clinical testing helps to determine whether a new substance is likely to cause serious adverse events in humans, and whether it should be progressed to clinical trials. While this has been the case for many ...
09 October 2009
We are all aware of a sponsor’s requirement to select investigators who are, as it states in the US Code of Federal Regulations, "qualified by training and experience as appropriate experts to investigate the drug" 1 in accordance with good clinical practices. However, the current competitive ...
09 October 2009
Acne, the scourge of teenagers, is a chronic condition associated with blockage of the pilosebaceous ducts typically on the face, chest and back. The blockage is manifested as a comedo or ‘blackhead’ – the pigmentation is caused by melanin arising from the hair. In cases with more severe blockage ...
 
 
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