Abstract The Regulation and approval process of medical devices are different from regulation and approval process of medicinal products. For instance, in the US, medical devices are regulated by the… read more →
Abstract Pharmaceutical products are not limited to therapeutic drugs and biologics. These pharmaceutical products are regulated by different branches of medicinal product’s regulatory agency. In the US, the center for… read more →
The establishment of medicinal regulatory agency’s intent is in facilitating and protecting public health interest by ensuring the safety and efficacy evaluation of medicinal products (biologics, devices, drugs) and other… read more →
Innovations or inventions have many mothering factors. One of the major enticing factor is profitable societal and unmet needs. There are also altruism and noble causes driven by the optimism… read more →
Abstract Evaluating the quality of clinical data is the basis of achieving accurate conclusions in rejecting or not rejecting the null hypothesis for a research or study (Hattemer-Apostel et. al.,… read more →
One of the most important aspects of data collection and analysis in a clinical study is creating quality assurance sources which will ensure data integrity. As the globalization of clinical… read more →
It is important to realize the impacts of the environmental or extrinsic factors to the quality of life and gene function such as gene expression, modification, stabilization and human behavior.… read more →
Genetically, physiologically, physically, chemically, emotionally etc, men and women are different. The gender differences are clearly relevant to some degrees to valid discussion in several subject matters. However, in the… read more →
The importance of biomarkers/genetic markers cannot be overstated. Biomarkers are one of the most integral part of clinical research and science. In a nutshell, biomarkers are the objective physical or… read more →
Conducting clinical research studies, and selecting appropriate subjects within the inclusion criteria is the key to a successful ethical scientific study (Dombey, Markel, & Derenzo, 2012). In any clinical trial,… read more →
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