Hydrobromide Salt Formulation Sample Clauses

Hydrobromide Salt Formulation. An analysis of chloride levels in subjects on Study EZH-102 at the 1200 mg/m2 dose level showed elevated chloride levels (beyond the ULN) in 5/7 subjects who had been treated at this dose level. Reviewing this finding further, subjects at lower dose levels (4/6 subjects at 900 mg/m2, 4/6 subjects at 700mg/m2 and 4/6 subjects at 520 mg/m2) also demonstrated elevated chloride levels. Hyperchloremia is considered an artifact resulting from interference of serum bromide with the serum chloride assay (tazemetostat is a bromide salt). Artifactually elevated serum chloride was also noted in repeat-dose nonclinical toxicology studies of tazemetostat in rats and monkeys at tazemetostat doses up to 1000 mg/kg/day. Ion exchange chromatography showed increased serum chloride in these nonclinical studies to be pseudo-hyperchloremia, representing increased bromide. Bromide levels were measured in the Phase 1 study of tazemetostat in adults. Bromide was within normal levels (<6.2 mmol/L) for all subjects taking the oral tablet formulation in doses up to 1600 mg BID. However, mean tazemetostat AUC(0-24) in children at the 1200 mg/m2 dose level exceeded that observed in the 1600 mg BID dose group in adults from Study E7438- G000-101. Therefore, the assessment of bromide levels was instituted in Amendment No. 5 for all active and new subjects. Refer to Section 8.5.10 and Table 11 for the schedule of bromide level assessments and to Section 6.5.2 for dose modifications due to bromide toxicity. The chloride assay is being collected locally at every visit as part of the electrolyte panel, which is included in the standard blood chemistry assessment (Table 11). For more details, refer to the tazemetostat Investigator’s Brochure, Version 10.0.
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Related to Hydrobromide Salt Formulation

  • RE-WEIGHING PRODUCT Deliveries are subject to re- weighing at the point of destination by the Authorized User. If shrinkage occurs which exceeds that normally allowable in the trade, the Authorized User shall have the option to require delivery of the difference in quantity or to reduce the payment accordingly. Such option shall be exercised in writing by the Authorized User.

  • Influenza Vaccine Upon recommendation of the Medical Officer of Health, all employees shall be required, on an annual basis to be vaccinated and or to take antiviral medication for influenza. If the costs of such medication are not covered by some other sources, the Employer will pay the cost for such medication. If the employee fails to take the required medication, she may be placed on an unpaid leave of absence during any influenza outbreak in the home until such time as the employee has been cleared by the public health or the Employer to return to the work environment. The only exception to this would be employees for whom taking the medication will result in the employee being physically ill to the extent that she cannot attend work. Upon written direction from the employee’s physician of such medical condition in consultation with the Employer’s physician, (if requested), the employee will be permitted to access their sick bank, if any, during any outbreak period. If there is a dispute between the physicians, the employee will be placed on unpaid leave. If the employee gets sick as a reaction to the drug and applies for WSIB the Employer will not oppose the application. If an employee is pregnant and her physician believes the pregnancy could be in jeopardy as a result of the influenza inoculation and/or the antiviral medication she shall be eligible for sick leave in circumstances where she is not allowed to attend at work as a result of an outbreak. This clause shall be interpreted in a manner consistent with the Ontario Human Rights Code.

  • Hepatitis B Vaccine Where the Hospital identifies high risk areas where employees are exposed to Hepatitis B, the Hospital will provide, at no cost to the employees, a Hepatitis B vaccine.

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  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.