Which of the following steps comes immediately before Phase I clinical testing?

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BlackTom AI · Accepted Answer

Here's how to evaluate each option in the context of preclinical to clinical development steps.
Option a) 'Post-marketing safety review' would occur after a product is approved and marketed, not before Phase I. This is part of Phase IV post-marketing surveillance, so it cannot come immediately before Phase I.
Option b) 'Placebo comparison trials' are typically part of later-phase efficacy testing (Phase III or sometimes Phase II depending on design), not the step immediately preceding Phase I. Phase I usually focuses on safety and pharmacology in a small number of healthy volunteers or patients, not large-scale comparative trials.
Option c) 'Laboratory studies' refer to preclinical work, including in vitro and animal studies that establish safety and biological activity before any human exposure. This is precisely what is required immediately prior to initiating Phase I clinical testing, and it is the conventional preclinical gatekeeping step.
Option d) 'Human dosing studies' would be part of Phase I itself or related first-in-human work, where initial dosing and safety are assessed in humans. They do not precede Phase I; they constitute Phase I activities.
In summary, the only option that aligns with the established order—preclinical laboratory investigations conducted before any human Phase I trials—is option c, Laboratory studies.

Which of the following steps comes immediately before Phase I clinical testing?

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