Regulatory Affairs Certification (RAC) Practice Exam 2025 - Free RAC Practice Questions and Study Guide

The primary goal of the preclinical phase of drug development is to assess safety and biological activity. During this critical stage, researchers conduct experiments using in vitro (test tube or cell culture) and in vivo (animal) models to evaluate how a potential drug interacts with biological systems. This includes identifying any toxic effects, determining the pharmacokinetics (how the drug is absorbed, distributed, metabolized, and excreted), and establishing overall efficacy in producing the desired therapeutic effects.

This phase is essential to ensure that the drug is safe enough to proceed to human trials. By gathering this information, developers can make informed decisions about whether to advance to the clinical phase, where the drug will be tested in humans. The insights gained at this stage are crucial to refining the drug's formulation and understanding its potential benefits and risks.

Other options, including market demand, post-market surveillance, and packaging requirements, are not primary goals of the preclinical phase. Market demand is typically evaluated later in the development process, while post-market surveillance occurs after a drug is approved and available to the public, and packaging requirements are addressed closer to the end of development when preparing for commercial distribution.