PK and Sample Clauses

PK and drug metabolism in animals • Intravenous (IV) pharmacokinetics (PK) of ETX2514 in rats were generally dose proportional with increasing dose. Exposure in males and females was comparable. Short half-lives of 0.23 and 0.80 hours in rats and dogs, respectively, resulted in no accumulation. Steady state volume of distribution (Vdss) ranged from 0.44 to 0.59 L/kg in rats and from 0.26 to 0.32 L/kg in individual dogs. • Protein binding of ETX2514 was very low with the percentage of unbound ETX2514 ranging from 78.3% to 100% across human, mouse, dog, rat, and guinea pig, with no evidence of saturation or concentration dependence. • In vitro, ETX2514 was metabolically stable in rat, dog, and human hepatocytes as well as rat and dog microsomes. • ETX2514 showed no significant inhibition of cytochrome P450 (CYP) enzymes, no in vitro evidence for induction potential, and no inhibitory potency against major transporters within a clinically relevant exposure range. • Clearance of ETX2514 in rats and dogs was predominantly via urinary excretion (59% and 71%, respectively). In vitro studies confirmed ETX2514 is a substrate for the kidney transporter OAT1 at concentrations in excess of 500 µM. This transport was inhibited competitively with the addition of probenecid.
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Related to PK and

  • Documents and Records Seller shall deliver to Servicer, and Servicer shall hold in trust for Seller and the Purchasers in accordance with their respective interests, all documents, instruments and records (including, without limitation, computer tapes or disks) that evidence or relate to Pool Receivables.

  • Documents The Warrant Agent shall be protected and shall incur no liability for or in respect of any action taken or omitted by it in reliance upon any Warrant Certificate, notice, direction, consent, certificate, affidavit, statement or other paper or document reasonably believed by it to be genuine and to have been presented or signed by the proper parties.

  • Requesting Records A request for inspection and/or copies of public records must be made in writing and may be submitted by personal delivery, mail, telefax, or email directed to the District's Freedom of Information Officer.Individuals making a request are not required to state a reason for the request other than to identify when the request is for a commercial purpose or when requesting a fee waiver. The Superintendent or designee shall instruct District employees to immediately forward any request for inspection and copying of a public record to the District's Freedom of Information Officer or designee.

  • Document Retention As used in this Section 15.2, the term “Documents” shall mean all files, documents, books, records and other data delivered to Buyer by Seller pursuant to the provisions of this Agreement (other than those that Seller has retained either the original or a copy of), including: financial and tax accounting records; land, title and division of interest files; contracts; engineering and well files; and books and records related to the operation of the Assets prior to the Closing Date. Buyer shall retain and preserve the Documents for a period of no less than seven years following the Closing Date (or for such longer period as may be required by law or governmental regulation), and shall allow Seller or its representatives, at Seller’s expense, to inspect the Documents at reasonable times and upon reasonable notice during regular business hours during such time period. Seller shall have the right during such period to make copies of the Documents at its expense.

  • Weights light, moderate and heavy, have their normal everyday meanings, and are to be applied consistently, regardless of the physical characteristics of the jobholder and whether the duties are normally carried out by women or by men; or by small people or large people; or by fit or unfit people. So, a sack of cement or a sack of potatoes is a heavy weight, even if it is lifted and carried without obvious exertion by a tall, fit, young person.

  • Training Records A. Employees may request a copy of their training record. The Employer will provide either a hard copy or electronic access to their training record. If an employee provides documentation to the Employer of work-related training it will be recorded in the training record or the employee personnel file.

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  • Late Arrivals If you plan to arrive more than five (5) days after your Move-In Date, you must notify Student Housing and Community Services in writing. If you do not move into your accommodation within five (5) days of your Move-In Date, this Contract may be cancelled and your accommodation will be reassigned without further notice.

  • Access Rights Upon reasonable notice and supervision by the Granting Party, and subject to any required or necessary regulatory approvals, either the Connecting Transmission Owner or Developer (“Granting Party”) shall furnish to the other of those two Parties (“Access Party”) at no cost any rights of use, licenses, rights of way and easements with respect to lands owned or controlled by the Granting Party, its agents (if allowed under the applicable agency agreement), or any Affiliate, that are necessary to enable the Access Party to obtain ingress and egress at the Point of Interconnection to construct, operate, maintain, repair, test (or witness testing), inspect, replace or remove facilities and equipment to: (i) interconnect the Large Generating Facility with the New York State Transmission System; (ii) operate and maintain the Large Generating Facility, the Attachment Facilities and the New York State Transmission System; and (iii) disconnect or remove the Access Party’s facilities and equipment upon termination of this Agreement. In exercising such licenses, rights of way and easements, the Access Party shall not unreasonably disrupt or interfere with normal operation of the Granting Party’s business and shall adhere to the safety rules and procedures established in advance, as may be changed from time to time, by the Granting Party and provided to the Access Party. The Access Party shall indemnify the Granting Party against all claims of injury or damage from third parties resulting from the exercise of the access rights provided for herein.

  • Periodic Risk Assessment Provider further acknowledges and agrees to conduct periodic risk assessments and remediate any identified security and privacy vulnerabilities in a timely manner.

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