SOCRA CCRP Practice Exam

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What are CMC studies concerned with?

Patient recruitment strategies
Legal aspects of drug testing
Solubility, stability, and formulation of a new drug
The ethics of clinical trials

The correct answer is: Solubility, stability, and formulation of a new drug

CMC studies, or chemistry, manufacturing, and control studies, are concerned with the various chemical, physical, and biological characteristics of a new drug. This includes studying the drug's solubility, stability, and formulation, which directly impact its safety and efficacy. While patient recruitment strategies and the ethics of clinical trials are important aspects of drug testing, they are not specifically addressed in CMC studies. Additionally, while legal aspects may play a role in drug testing, they are not the main focus of CMC studies. Therefore, option C is the most accurate and complete choice.