There are many differences between clinical protocols designed for new and unapproved medicinal product’s approval process and protocols designed primarily to increase scientific knowledge. Therefore, addressing the FINER acronym; Feasible,… read more →
The Idea introduced by the international conference on harmonization (ICH) in universalizing medical terminology in clinical trials is brilliant and very important. The concept of the medical dictionary for regulatory… 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 →
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 →
Abstract As much as it is easy to assert that the advancement in medicinal products is possible through an active and effective clinical research. It is also as more important… 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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