PK Study definition

PK Study means a pharmacokinetics study.
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PK Study means a clinical study that generally provides for the first introduction into humans of a pharmaceutical product with the primary purpose of determining safety, metabolism and pharmacokinetic properties and clinical pharmacology of such product, in a manner that is generally consistent with 21 C.F.R. §312.21(a), as amended (or its successor regulation).
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PK Study means a pharmacokinetic study used to describe the absorption, distribution, metabolism, and excretion of a compound after introduction into animals or humans.
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Examples of PK Study in a sentence

  • Strong PipelineStrong Pipeline PRODUCT/ PROGRAM Pre-Clinical Phase 1 Phase 2 Phase 3 NDA Commercial Status ZOHYDRO® ER ER Hydrocodone Capsules For Chronic Pain 2 AD Formulations RELDAY TM Monthly SQ Risperidone for Schizophrenia Undisclosed DosePro CNS Product Candidate(s) Undisclosed N/A N/A Approved October 25 2013 Launched March 3rd 2014 • Targeting Late 2016 • MD PK Study in 2H 2014 Pre-IND Mtg Nov.

  • Estimated and actual expenses 2.2Non-Clinical Development (WBS 2.2 — reserved)2.3Non-Clinical Biodefense (WBS 2.3 — reserved)2.4Clinical (WBS 2.4)2.4.1 Phase 1 (WBS 2.4.1)2.4.1.1 Phase lb Pediatric PK Study (WBS 2.4.1.1): The Contractor will conduct a multiple dose PK and safety study in pediatrics.

  • Phase lb Pediatric PK Study (WBS 2.4.1.1): The Contractor will conduct a multiple dose PK and safety study in pediatrics.

  • If SFJ elects to conduct any PK Study in Japanese Subjects in the US or Chinese Subjects in the US, PB shall, with SFJ’s assistance and cooperation, file an appropriate amendment to the US IND for the Product with the protocol for such PK Study, and SFJ may conduct such PK Study in the applicable Subjects in the US in accordance with such protocol.

  • During the term of this agreement, SKS shall provide to Alcon, for no additional consideration, any assistance and technical expertise reasonably requested by Alcon to support the PK Study.

  • CaPre® was safe and well tolerated, with no safety concerns.Following receipt of data for the Phase I PK Study and the Phase II clinical trials – COLT and TRIFECTA – Acasti provided a data package to the FDA to receive direction on requirements for the pivotal Phase III clinical program.Next StepsAcasti is now corresponding with the FDA about the next steps proposed for the clinical development plan of CaPre®.

  • RESPONSE TO COMMENT 4: Because the Company was able to demonstrate, in its open-label Phase 2 human pharmacokinetic clinical study (PK Study) through month 18, that the use of Iluvien results in negligible systemic absorption of fluocinolone acetonide (FA), the Company expects that it will obtain a waiver from regulatory agencies for the requirement to perform carcinogenicity studies in animals.

  • The Contractor will submit the Phase la Adolescent PK Study protocol to the SOLI capsule IND prior to enrollment of the first patient.

  • Phase 1b Pediatric PK Study (WBS 2.4.1.1): The Contractor will conduct a multiple dose PK and safety study in pediatrics.

  • Strong Pipeline PRODUCT/ PROGRAM Pre-Clinical Phase 1 1 Phase 2 Phase 3 NDA Commercial Status Zohydro ER ER Hydrocodone Capsules For Chronic Pain Approved October 25 2013 Launched March 3rd 2014 2 AD Formulations N/A N/A • Targeting Late 2016 RELDAY Monthly SQ Risperidone for Schizophrenia • MD PK Study in 2H 2014 Undisclosed DosePro CNS Product Candidate(s) Undisclosed Pre-IND Mtg Nov.

Related to PK Study

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • 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).

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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.

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

  • 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.

  • 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 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

  • Phase 2 Clinical Trial means a human clinical trial of a product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(b), as amended, and is intended to explore a variety of doses, dose response, and duration of effect, and to generate evidence of clinical safety and effectiveness for a particular Indication or Indications 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 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • Phase III Trial means a human Clinical Trial of the Licensed Product, which trial is designed (a) to establish that the Licensed Product is safe and efficacious for its intended use; (b) to define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; and (c) consistent with 21 CFR § 312.21(c).

  • Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.

  • 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.

  • Phase III Clinical Trial means a human clinical trial in any country, the results of which could be used to establish safety and efficacy of a Product as a basis for an NDA or would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • Phase 1 Clinical Trial means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • 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 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.

  • Phase 1 Trial means, with respect to a Product, a human clinical trial that is intended to initially evaluate the safety, metabolism and pharmacokinetics of such Product that would otherwise satisfy the requirements of 21 C.F.R. 312.21(a) or an equivalent clinical trial in a country other than the United States.