Phase I Clinical Trial definition: Copy, customize and use instantly
Introduction
The term "Phase I Clinical Trial" refers to the initial stage of clinical research where investigational drugs or treatments are tested in human subjects. It is essential for evaluating safety, dosage range, metabolism, and potential side effects before progressing to further phases of clinical trials.
Below are various examples of how "Phase I Clinical Trial" can be defined in different contexts. Copy the one that fits your needs, customize it, and use it in your contract.
Definition of "Phase I Clinical Trial" as an early-stage study
This definition ties "Phase I Clinical Trial" to its role in first-in-human testing.
"Phase I Clinical Trial" means a clinical study conducted with a small number of participants to evaluate the safety, tolerability, and pharmacokinetics of an investigational drug or therapy.
Definition of "Phase I Clinical Trial" as a safety assessment
This definition connects "Phase I Clinical Trial" to its primary focus on safety evaluation.
"Phase I Clinical Trial" refers to the initial phase of human testing, designed to determine the safe dosage levels, potential side effects, and metabolic pathways of a new drug.
Definition of "Phase I Clinical Trial" as a dose-escalation study
This definition links "Phase I Clinical Trial" to determining appropriate dosage levels.
"Phase I Clinical Trial" means a clinical investigation where an investigational product is administered in increasing doses to identify the maximum tolerated dose and potential adverse effects.
Definition of "Phase I Clinical Trial" as a pharmacokinetic evaluation
This definition applies "Phase I Clinical Trial" to studying how the body processes a drug.
"Phase I Clinical Trial" refers to a controlled study aimed at assessing absorption, distribution, metabolism, and excretion (ADME) characteristics of an investigational compound in humans.
Definition of "Phase I Clinical Trial" as a first-in-human trial
This definition ties "Phase I Clinical Trial" to its status as the first step in human clinical testing.
"Phase I Clinical Trial" means the earliest phase of clinical development where a drug is tested in healthy volunteers or patients to evaluate safety, pharmacological properties, and preliminary effectiveness.
Definition of "Phase I Clinical Trial" as an exploratory study
This definition ties "Phase I Clinical Trial" to its role in exploring early drug effects.
"Phase I Clinical Trial" means an initial clinical study that investigates the biological and pharmacological responses of an investigational product in a controlled setting.
Definition of "Phase I Clinical Trial" as an investigational drug trial
This definition connects "Phase I Clinical Trial" to its use in assessing new pharmaceuticals.
"Phase I Clinical Trial" refers to the first phase of clinical testing where a new drug or biologic is administered to human subjects to evaluate safety and tolerability.
Definition of "Phase I Clinical Trial" as a regulatory requirement
This definition links "Phase I Clinical Trial" to compliance with regulatory frameworks.
"Phase I Clinical Trial" means a study conducted in accordance with regulatory guidelines to determine the safety profile of a novel therapeutic agent before advancing to later clinical phases.
Definition of "Phase I Clinical Trial" as a controlled human study
This definition applies "Phase I Clinical Trial" to initial human testing under controlled conditions.
"Phase I Clinical Trial" refers to the first-in-human stage of clinical development, where a new drug is tested under strictly controlled conditions to assess its safety and pharmacodynamics.
Definition of "Phase I Clinical Trial" as a patient or volunteer study
This definition ties "Phase I Clinical Trial" to the use of healthy volunteers or specific patient populations.
"Phase I Clinical Trial" means an early-phase clinical investigation where an experimental drug is administered to healthy individuals or selected patients to determine appropriate dosing strategies.
Definition of "Phase I Clinical Trial" as an investigational assessment
This definition connects "Phase I Clinical Trial" to determining a drug’s potential risks.
"Phase I Clinical Trial" refers to a clinical investigation designed to establish the risk-benefit profile of a new treatment through initial human exposure.
Definition of "Phase I Clinical Trial" as a safety validation process
This definition links "Phase I Clinical Trial" to validating the initial safety of a treatment.
"Phase I Clinical Trial" means a systematic evaluation of a new drug or therapy in human subjects to confirm initial safety findings from preclinical research.
Definition of "Phase I Clinical Trial" as a pharmaceutical development phase
This definition applies "Phase I Clinical Trial" to drug development pipelines.
"Phase I Clinical Trial" refers to the first phase of human testing in a multi-stage clinical research process designed to bring new pharmaceuticals to market.
Definition of "Phase I Clinical Trial" as a necessary prerequisite
This definition ties "Phase I Clinical Trial" to its necessity before proceeding to later clinical phases.
"Phase I Clinical Trial" means the initial human study required before a drug candidate can move into expanded patient trials, ensuring fundamental safety is established.
Definition of "Phase I Clinical Trial" as a feasibility study
This definition connects "Phase I Clinical Trial" to assessing feasibility in human subjects.
"Phase I Clinical Trial" refers to an early-stage investigation that evaluates whether a new therapy has a viable safety and dosing profile before further clinical development.
Definition of "Phase I Clinical Trial" as an ethical clinical assessment
This definition links "Phase I Clinical Trial" to ethical considerations in drug testing.
"Phase I Clinical Trial" means a clinical investigation conducted under strict ethical guidelines to protect participants while evaluating the initial effects of a new drug.
Definition of "Phase I Clinical Trial" as an experimental treatment assessment
This definition applies "Phase I Clinical Trial" to experimental treatment testing.
"Phase I Clinical Trial" refers to an investigational study where an experimental drug or therapy is first administered to humans to assess its basic safety parameters.
Definition of "Phase I Clinical Trial" as a proof-of-concept study
This definition ties "Phase I Clinical Trial" to demonstrating an initial proof of concept.
"Phase I Clinical Trial" means a preliminary study conducted to establish whether a new drug or biologic exhibits the intended therapeutic activity in human subjects.
Definition of "Phase I Clinical Trial" as a preliminary safety evaluation
This definition connects "Phase I Clinical Trial" to its role in confirming preclinical safety findings.
"Phase I Clinical Trial" refers to a controlled study in which an investigational drug is tested in a small group of subjects to verify safety before wider clinical use.
Definition of "Phase I Clinical Trial" as a pharmacological screening
This definition links "Phase I Clinical Trial" to its role in screening for pharmacological activity.
"Phase I Clinical Trial" means a phase of clinical research where a new drug's effects on biological systems are systematically evaluated for safety and efficacy signals.
Definition of "Phase I Clinical Trial" as a risk assessment study
This definition applies "Phase I Clinical Trial" to assessing initial risks in humans.
"Phase I Clinical Trial" refers to a trial designed to identify potential risks and adverse effects of an investigational compound before progressing to broader human testing.
Definition of "Phase I Clinical Trial" as a human pharmacodynamics study
This definition ties "Phase I Clinical Trial" to understanding a drug’s effects in humans.
"Phase I Clinical Trial" means an investigation where the pharmacodynamic responses of a new drug are measured to determine how it affects biological functions.
Definition of "Phase I Clinical Trial" as an early intervention assessment
This definition connects "Phase I Clinical Trial" to evaluating early-stage therapeutic interventions.
"Phase I Clinical Trial" refers to an initial clinical study designed to assess whether a novel therapeutic approach is safe for continued clinical development.
Definition of "Phase I Clinical Trial" as an experimental medicine trial
This definition links "Phase I Clinical Trial" to research in novel medicine development.
"Phase I Clinical Trial" means a study undertaken to test the feasibility and safety of a new medicinal compound in human subjects for the first time.
Definition of "Phase I Clinical Trial" as a bioequivalence test
This definition applies "Phase I Clinical Trial" to bioequivalence testing of new formulations.
"Phase I Clinical Trial" refers to an early-phase study in which the bioequivalence of different formulations of a drug is assessed in human participants.
Definition of "Phase I Clinical Trial" as a clinical feasibility analysis
This definition ties "Phase I Clinical Trial" to determining clinical feasibility before large-scale studies.
"Phase I Clinical Trial" means an early-stage study that assesses whether an investigational drug shows promise for further development in human medicine.
Definition of "Phase I Clinical Trial" as an initial regulatory submission study
This definition connects "Phase I Clinical Trial" to regulatory submission requirements.
"Phase I Clinical Trial" refers to a clinical study conducted as part of the data submission required for regulatory approval of an investigational new drug.
Definition of "Phase I Clinical Trial" as a clinical pharmacology study
This definition links "Phase I Clinical Trial" to detailed pharmacological research.
"Phase I Clinical Trial" means a study where a drug’s clinical pharmacology, including its mechanism of action and interaction with human systems, is evaluated in real-world conditions.
Definition of "Phase I Clinical Trial" as an early-stage drug safety test
This definition ties "Phase I Clinical Trial" to assessing drug safety before further clinical phases.
"Phase I Clinical Trial" means a study designed to test the safety, tolerability, and appropriate dosing of a new drug in a small group of human subjects before progressing to later stages of development.
Definition of "Phase I Clinical Trial" as an investigational human trial
This definition connects "Phase I Clinical Trial" to its role in first-in-human testing.
"Phase I Clinical Trial" refers to an initial human study where a novel therapeutic compound is administered to evaluate its safety, metabolism, and pharmacokinetics.
Definition of "Phase I Clinical Trial" as a controlled clinical experiment
This definition links "Phase I Clinical Trial" to its role in a controlled clinical research setting.
"Phase I Clinical Trial" means a controlled study conducted to determine the preliminary effects of a drug or treatment in human subjects under strict medical supervision.
Definition of "Phase I Clinical Trial" as a foundational study in drug development
This definition applies "Phase I Clinical Trial" to the broader pharmaceutical development process.
"Phase I Clinical Trial" refers to the first stage of clinical research where a new investigational drug is tested in a limited number of participants to establish a foundation for further clinical testing.
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