Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...

According to obedience research, we may harm others under the forceful pressures of an authority figure (Milgram, 1974). How about if the inappropriate orders were delivered with less force? The increasing interdependence between nurses and physicians compelled Hofling and his colleagues to explore nurses’ reactions to a potentially harmful medical request made by the perceived authority figure, the doctor (Hofling, Brotzman, Dalrymple, Graves, & Pierce, 1966). In this situation,...

Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.