Dose Justification Sample Clauses

Dose Justification. To date, the current capsule utilized in clinical studies is not associated with a maximum tolerated dose (MTD). Initial MTD assessments were performed using SAGE-217 in an oral solution (OS) at steady-state in healthy participants, which provided an MTD with a Cmax of 125 ng/mL at 30 mg OS. While reidentification of the MTD using the capsule formulations was not conducted, steady-state 30-mg capsules provide a model-derived Cmax approximately 50% lower (64 ng/mL) than the concentration associated with the MTD of 30 mg OS (125 ng/mL). Studies 217-MDD-201 and 217-PPD-201, employing 30-mg capsules administered each evening for 14 days, demonstrated significant reduction in symptoms of depression, anxiety and insomnia. The safety profile in these studies is consistent with the GABAA neurosteroid mechanism, including adverse drug reactions (ADRs) of somnolence, sedation, and dizziness at rates of 4% to 15%; the majority with mild intensity. Phase 3 studies in a broader patient population demonstrate activity of SAGE-217 associated with improvement in depressive symptoms, however, both the efficacy and safety findings support investigation of a higher dose, with predictable ADRs expected to be within an acceptable range. Study 217-MDD-301A, a randomized, multicenter, 3-arm study examining SAGE-217 20-and 30-mg capsules compared to placebo, found significant antidepressant effects compared to placebo at Days 3, 8, and 12 but not Day 15 (primary endpoint) for the 30-mg dose. The 20-mg dose did not separate from placebo at any time point. The rates of expected ADRs of somnolence, sedation and dizziness in the 30-mg arm were each less than 10%; rates of discontinuation for adverse events were lower with SAGE-217 30 mg (2.1%) than with placebo (3.2%). No clinically relevant changes in xxxxx xxxxx, laboratory results, electrocardiogram measures, or suicidal thinking were observed in either 217-MDD-301A or across the full SAGE-217 program, now with over 2000 participants exposed to treatment. Relevant results from 217-MDD-301A are available in the Investigator’s Brochure. Direct and modeled data from completed studies to date (including efficacy studies 217-MDD-201 and 217-PPD-201) in addition to 217-MDD-301A (through Day 42 of the double-blind period), have been used to assess and predict the efficacy and safety outcomes at SAGE-217 concentrations expected with higher doses of SAGE-217 capsules (eg, 40 and 50 mg). Direct safety data come from more than 140 participan...
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Dose Justification. 5.4.1. Safety Measures

Related to Dose Justification

  • Rationale/Justification The Cisco Certified Network Associate Security (CCNA® Security) certification represents industry acknowledgement of technical skill attainment of competencies in the IT Security program.

  • Justification For fishing of marine fish, prawn, and other aquatic organism, different treatment is given to Myanmar citizens according to the provisions of the Myanma Marine Fisheries Law (1990).

  • PURPOSE/JUSTIFICATION OF RECOMMENDED ACTION The TTC will sell the properties in accordance with the provisions of Division 1, Part 6, Chapter 8 of the Revenue and Taxation Code (R&TC), and the Board of Supervisors' policy adopted on November 24, 1970. Exhibit A of the Chapter 8 Agreement Sale indicates the legal description and selling price of the properties. The Honorable Board of Supervisors 3/5/2019 The recommended action supports County Strategic Plan Strategy III.3 – Pursue Operational Effectiveness, Fiscal Responsibility, and Accountability.

  • Notification to Unsuccessful Job Applicants The parties agree that any unsuccessful candidate for an ONA job posting will be notified, in writing, within one (1) week of the decision being made and prior to the posting of the name of the successful candidate. The parties further agree that the above notification will be copied to the ONA Bargaining Unit President.

  • Justification for the Request The request for a supplemental funding for any of the above-mentioned programs should contain a justification clearly documenting the need for the additional funding authority during the current quarter. This documentation should be in the form of State accounting records or similar documents that will show the actual expenditures through the most recent month for which such data are available, as well as the State's most accurate projection of its anticipated expenditures during the remaining month(s) of the quarter. For either the TANF or the CCDF program, the State's justification should also include an explanation of the activities requiring the obligation and/or expenditure of amounts that exceed the normal quarterly grant award restrictions and why these activities could not have been delayed until the next quarter.

  • Recall Notification Notice of recall shall be sent to the bargaining unit member by certified mail. The City shall be deemed to have fulfilled its obligation by mailing the recall notice by certified mail, return receipt requested, to the last address provided by the bargaining unit member.

  • Office of Inspector General Investigative Findings Expert Review In accordance with Senate Bill 799, Acts 2021, 87th Leg., R.S., if Texas Government Code, Section 531.102(m-1)(2) is applicable to this Contract, Contractor affirms that it possesses the necessary occupational licenses and experience.

  • Recall Employees who have been laid off shall be re-employed in seniority order from most senior to least senior. Employees whose positions have been eliminated through layoff or otherwise, shall be called first to fill a vacancy within their job family. 1. Prior to other employees being recalled from the recall list, an employee who displaced another employee pursuant to provisions contained in this article shall have the right to be recalled to a vacant position for which they are qualified. However, the employee who displaces another employee shall not be eligible for a position at a higher pay grade than the one he/she originally held at the time of layoff. If the employee who displaced another employee fills a vacancy in his/her original department, then the employee whom he/she displaced will automatically be recalled into the position from which he/she previously held. After this process, other employees will be recalled to fill a vacancy for which they are qualified in the same department they were assigned at the time of their layoff. 2. Employees may be offered a position outside their department/program for which they are qualified. Employees may refuse a position outside their department/program. Employees who refuse such a position a second time shall have no further rights to recall. 3. Each employee on layoff shall be required to provide the District Personnel Office, in writing, with a current address to which a letter of recall may be sent. Employees being recalled shall be notified by “Certified Mail Delivery Confirmation” and shall have five (5) working days from the date of the receipt of notice to respond to the School Board’s offer and return to work. The School Board reserves the right to temporarily assign an employee to the vacancy until the recalled employee reports to work. If the letter is mailed to the address provided by the employee and is returned to the School Board because the address is incorrect, the School Board has fulfilled the obligation of this sub-section. If the School Board does not receive an affirmative response, the employee will be moved to the bottom of the recall list. If the recall notice is returned in the allotted time, yet not marked appropriately by the Human Resources & Equity Department, the employee shall retain his/her place on the recall list for the next job opening for which he/she is qualified. However, after the third returned notice, the employee’s name will be dropped from the recall list and the School Board shall have no further obligation to the employee. 4. An employee whose contract is non-renewed due to reorganization shall be entitled to recall rights for a layoff period of eighteen (18) months. All other employees shall be entitled to recall rights for a layoff period of twelve (12) months. 5. The employee laid off pursuant to this Article shall be given the opportunity to continue insurance coverages in existing programs during the layoff provided that the premium for such insurance programs shall be paid by the employee on a monthly basis in advance of the month due. 6. No new or substitute appointments may be made while there are laid off employees available who are qualified to fill the vacancies, except that employees may be hired into positions that have been offered and refused by employees on the layoff/recall list.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Complaints Investigation The employee who complains of harassment under the provisions of the Human Rights Code must first comply with the Employer’s harassment policy procedures before filing a grievance or human rights complaint.

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