In discussing risks and benefits, the institutional review board (IRB) often discusses what makes incentives coercive or non-coercive. However, evaluating whether or not an incentive is coercive is a case… 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 purpose of any scientific research is to make predictions, hypothesize, ask questions and derive a deductive answer to a given question. Preclinical studies in animal employ pharmacokinetics, pharmacodynamics and… read more →
Living things including humans are wounded deeply from birth, a chasm naked eyes may not see, but it is subject to the extrinsic factor’s temerity to become apparent. An exposure… read more →
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 →
One of the core function of public health is to ensure/assure conducive environment for a healthy living by implementing necessary health related policies that will improve the quality of life.… 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 →
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 →
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