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 main objective of risk management and minimization assessment is tailored in protecting subject’s well-being, welfare and privacy, in clinical studies. Thus, it is important to understand that investigational medicinal… read more →
The international conference on harmonization (ICH5) bridging study’s idea was adopted in 1998 as a practical concept in enhancing globalization of clinical trials. The rationale necessitating the bridging studies, includes… read more →
Internet market place is a rapidly evolving as the new era pharmacy store. About 70% of medicinal products are purchased online yearly (Henney, 2010). This is indicative of how the… read more →
Dietary supplement is one of the fast growing product in the market. According to the 1994 US dietary supplement health and education act (DSHEA), “Dietary supplement” is defined as “Food”.… read more →
Abstract Although the food and drug administration (FDA) was not known by its present name until 1930, yet the agency has been active and was created from the Bureau of… read more →
Globally, many nations have been working to improve the regulatory guidelines for medicinal products. In the US, the 1962 Food, Drug and Cosmetic Act, gave the US food and Drug… read more →
Clinical research is a time consuming process because of the risks involved. Based on the ICH-E6 clinical research guidelines, “A sponsor may transfer any or all of the sponsor’s trial-related… read more →
Biotechnology startup companies and University research facilities are the primary source of innovation in drug and device development process (Ashbrook, & Sunkara, 2012). Some of the key reasons why startups… read more →
Patent protection is designed to protect intellectual property (IP) and new invention. The primary inventor(s) may have a patent or market exclusivity depending on the nature of the patent grant.… read more →
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