SOCRA CCRP Practice Exam

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What is the focus of Phase 0 in drug development?

PK/PD
Efficacy
Safety
Post-marketing surveillance

The correct answer is: PK/PD

Phase 0 of drug development is the first step in the process and focuses on the pharmacokinetics (PK) and pharmacodynamics (PD) of a drug. This means studying how the body absorbs, distributes, metabolizes, and excretes the drug, as well as its effects on the body. This information is crucial in determining the safe and effective dosage for the drug in later stages of development. B and D are incorrect because efficacy and post-marketing surveillance are not the main focus of Phase 0. While efficacy (the ability to produce a desired effect) is important, it is typically studied in later phases of development. Post-marketing surveillance is also not relevant during Phase 0, as it takes place after a drug is approved and on the market. C is incorrect because while safety is an important aspect of drug development, it is not the main focus of