Clinical Pharmacology Studies definition

Clinical Pharmacology Studies means studies in healthy volunteers or patients investigating the relationships between dose, drug exposure and response, as further described in the Development Plan.
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Clinical Pharmacology Studies means studies of the Lead Licensed Compound in healthy volunteers or patients investigating the relationships between dose, drug exposure, and response, as further described in the Clinical Pharmacology Study outlines contained in the Initial Development Plan.
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Clinical Pharmacology Studies means the Clinical Trials that are specified as the clinical pharmacology studies in the Initial Development Plan (Schedule 2).
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Examples of Clinical Pharmacology Studies in a sentence

  • Using Proc Power To Perform Model-Based Power Analysis For Clinical Pharmacology Studies.

  • APPEARS THIS WAY ON ORIGINAL Clinical Pharmacology Studies: The clinical pharmacology of avelumab (including PK, PK/PD, QTc, and immunogenicity assessments) has been characterized in Studies -001, -002, and -003 (See Applicant’s tables below).

  • Since then, the Bank has grown to fifteen locations in central and northwest Louisiana and recently surpassed $1 billion in total assets.

  • External Clinical Pharmacology Studies: Summary of TFV and TFV-DPPharmacokinetic Parameters in Various Biomatrices for Women 70Table 15.

  • Table 28 Summary Baseline Demographic Characteristics of PK Study (PWR Population) (Source: Summary of Clinical Pharmacology Studies, module 2.7.2, Table 2.7.2:9) Efficacy Study (P082)The PWR requirement for the efficacy study was for reasonable efforts be made to enroll similar number of subjects in the 12-14 and 15-17 year old age groups.

  • They also incorporate activities such as promotion of income-generating activities and participation in project planning processes aimed at ensuring that local communities derive benefits.

  • Comparison Across Clinical Pharmacology Studies of RPX7009 Pharmacokinetic Parameters (Mean ±SD) Following Single- and Multiple-Dose Administration of RPX7009 2 g Alone and in Combination with Meropenem (Preliminary Data) 35Table 3.

  • OBJECTIVES The Regulatory Guideline for Good Clinical Practice in Clinical Pharmacology Studies (GCP-CPS) herein establishes the requirements that sponsors and investigators must comply with within the scope of this agency´s authorization granting and monitoring duties.

  • However, like electric battery development, fuel cell technology is being studied intently with a focus on providing more cost-effective applications.

  • Comparison Clinical Pharmacology Studies with Nonliposome Drug Product The drug disposition and pathways of elimination (including distribution, metabolism and excretion) as well as several important pharmacokinetic measures (Cmax, AUC) and parameters (e.g., clearance, volume of distribution, half-life) of a liposome formulation are likely to be different than those of a nonliposome formulation given by the same route of administration.

Related to Clinical Pharmacology Studies

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • Studies means activities needed to prepare project implementation, such as preparatory, mapping, feasibility, evaluation, testing and validation studies, including in the form of software, and any other technical support measure, including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package;

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).