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

  • I regularly seek feedback on my performance from my superiors and colleagues to identify areas I need to improve in.Skills: reliability / leadership skills / self-awareness / technical skillsC Underline useful phrases from the extracts which you could use in your own cover letter.

  • 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).

  • 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.

  • List all transactions involving services and products received or provided.

  • Table 7 Listing of Clinical Studies Pediatric Clinical Pharmacology Studies with Rizatriptan: Phase 3 Pediatric Clinical Trials with Rizatriptan: (Source: Sponsor’s submission; Clinical Overview, module 2.5, Tables 2.5:1, 2.5:2) 5.2 Review StrategyThe efficacy review is based on one randomized, double-blind, placebo-controlled phase 3 trial: Protocol 082 (P082).

  • Background: See Company Position in Section 4.1 [Summary of Clinical Pharmacology Studies] of the Briefing Document.Does the Agency agree with Amgen’s plan to locate the summary of PK and immunogenicity results from Study 20110216 (pivotal PK study) in Module 2.7.2, recognizing that the full CSR will be included in Module 5.3.3.1? FDA Response: Yes, FDA agrees with the above proposal.

  • 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.

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

  • Please note that a Clinical Pharmacology and Biopharmaceutics review was not available at the time of completion of this review, and the information below was obtained from the sponsor’s Summary of Clinical Pharmacology Studies.

Related to Clinical Pharmacology Studies

  • Clinical Studies means any clinical studies of a Licensed Product conducted on humans.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • 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;

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • 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 pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • 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 human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • 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 large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • 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 post-registrational Clinical Trial conducted in any country or countries and required as a condition to, or for the maintenance of, any Regulatory Approval for a Product in the Territory.

  • 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 designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials 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.