PK Study definition

PK Study means a pharmacokinetics study.
View Source
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).
View Source
PK Study means a pharmacokinetic study used to describe the absorption, distribution, metabolism, and excretion of a compound after introduction into animals or humans.
View Source

Examples of PK Study in a sentence

  • During the period commencing on the Effective Date and ending on the date that is sixty (60) days after the date Alcon delivers to SKS the Results created during the PK Study, SKS shall not license or sell the SKS Technology to a Third Party for use with the Compound in the Field.

  • Novadel shall bear all costs and expenses incurred in providing a formulation for the Pilot PK Study as defined in Exhibit B or other mutually agreed to studies.

  • 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.

  • SKS shall also provide thereafter such additional quantities of the Study Formulations as Alcon may reasonably request to complete the PK Study.

  • SKS shall also provide thereafter such additional quantities of the Study Formulations as [redacted] may reasonably request to complete the PK Study.

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

  • During the period commencing on the Effective Date and ending on the date that is sixty (60) days after the date [redacted] delivers to SKS the Results created during the PK Study, SKS shall not license or sell the SKS Technology to a Third Party for use with the Compound in the Field.

  • 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.