Phase I clinical trials are the first stage of testing in human subjects, primarily focused on assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug. These trials typically involve a small number of healthy volunteers and aim to determine the appropriate dosage range and identify potential side effects.

Phase I Clinical Trials

First stage of testing

Human Subjects

Safety is the condition of being protected from harm or other non-desirable outcomes, often achieved through preventive measures and risk management. It encompasses a wide range of disciplines, including engineering, psychology, and public health, to ensure the well-being of individuals and communities.

Safety

Tolerability refers to the degree to which overt adverse effects of a drug or treatment can be tolerated by a patient. It is a critical factor in determining the viability and acceptance of medical therapies, balancing efficacy with the patient's quality of life.

Tolerability

Pharmacokinetics is the study of how drugs move through the body, encompassing absorption, distribution, metabolism, and excretion processes. It is crucial for understanding drug action, optimizing dosing regimens, and ensuring therapeutic efficacy while minimizing toxicity.

Pharmacokinetics

Pharmacodynamics is the study of how drugs affect the body, focusing on the mechanisms of action, the relationship between drug concentration and effect, and the therapeutic and toxic effects. It helps in understanding the drug's efficacy, potency, and safety profile, which are crucial for optimizing therapeutic regimens.

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