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Of course, such studies may also be required for a currently marketed drug that is undergoing safety and efficacy testing. To conduct thorough drug-drug interaction studies, pharmaceutical, biotechnology, and contract research organization (CRO) personnel typically need to conduct extensive study planning efforts, including the definition of appropriate study goals, the development of pertinent study protocols, and the recruitment of suitable subjects. In addition, the pharmaceutical industry's increasing reliance on CROs to conduct most of its clinical trials necessitates the development of effective communications protocols that facilitate seamless interactions between preclinical drug development and clinical research.
The best way to determine whether two drugs interact is to conduct a drug interaction study. A drug interaction study is a collaborative effort in which two or more investigators conduct identical studies with the same study drug and with or without the other drug of interest. A drug interaction study generally involves a formal protocol with a clearly defined sample size, inclusion and exclusion criteria, and a planned endpoint. The sample size is usually small, usually between 10 and 100 subjects. Hence, a drug interaction study might be considered as an exploratory clinical trial. A well-designed drug interaction study can provide evidence that certain drugs interact with each other.
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