Which of the following is not included in phase I clinical trial of medicine: March 2007
**Core Concept**
Phase I clinical trials are the first stage of testing in human subjects, primarily focusing on assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of a new drug or treatment. This phase involves a small group of healthy volunteers or patients with the target disease, with the goal of determining the maximum tolerated dose and identifying potential side effects.
**Why the Correct Answer is Right**
In phase I clinical trials, the primary objectives are to evaluate the safety and tolerability of a new drug, as well as its pharmacokinetic and pharmacodynamic profiles. This includes assessing the absorption, distribution, metabolism, and excretion (ADME) of the drug, as well as its effects on the body's physiological systems. The correct answer is related to the primary objective of phase I trials, which is to establish the safety and tolerability of the drug.
**Why Each Wrong Option is Incorrect**
**Option A:** This option might be related to the pharmacokinetic or pharmacodynamic profiles of the drug, which are indeed evaluated in phase I trials.
**Option B:** This option could be related to the safety and tolerability of the drug, which are also primary objectives of phase I trials.
**Option C:** This option might be related to the efficacy of the drug, which is typically evaluated in phase II and III trials.
**Clinical Pearl / High-Yield Fact**
It's essential to remember that phase I clinical trials primarily focus on safety and tolerability, rather than efficacy. This distinction is crucial in understanding the different phases of clinical trials and the objectives of each stage.
**Correct Answer: C. Efficacy.**