Best Quality Practices for Biomedical R&D

The public's interest is captured by the expectations provided by biomedical research and drug development. Besides the commercial value, the governmental and private funding support in the developed countries, primarily the US, provides the overarching hope of curing human illness and suffering, while providing the additional benefit of greater economic development. Obstructions to new drug entity breakthroughs have received much scrutiny since the recent decade-long decline in new drug approvals. [...]notwithstanding the doubling of biomedical research funding and the shift toward clinical research by pharmaceutical companies, "the number of new molecular entities approved by FDA has fallen. The purity, concentration, and stability of test articles and control articles (where used) can greatly affect the outcome and repeatability of a study or an experiment. [...]the purity, concentration, and stability and storage of test articles and control articles shall be specified and evaluated and documented periodically following standard operating procedures.