Animal Toxicology Sample Clauses

Animal Toxicology. Nonclinical safety assessments of tazemetostat included in vitro and monkey safety pharmacology studies, genotoxicity studies, and single- and repeat-dose toxicity studies in Xxxxxxx-Xxxxxx rats and cynomolgus monkeys of 4- and 13-weeks duration. No notable cardiovascular, central nervous system (CNS), or respiratory risks were identified in nonclinical safety pharmacology assessments. Tazemetostat was not genotoxic in standard in vitro and in vivo assays. CCI CCI CCI These studies were conducted in rats that, at initiation of dosing, were approximately 8 weeks old (adolescent rats; standard for support of dosing in adult patients) or 7 days old (juvenile rats; to support dosing of pediatric patients). CCI was not observed in 4- week studies in adolescent or juvenile rats. A brief summary of data from the 13-week studies is provided below in Table 3. Study Number Age of rats at start Tazemetostat doses CCI of study mg/kg/day K14009 ~8 week old adolescent rats 100 300 600 WIL-154506 Post-natal day 7 juvenile rats 50, 100 150/3001 150/600 1 Rats in the 2 highest dose groups were dosed at 150 mg/kg/day from post-natal day (PND) 7 to PND 21 and escalated to 300 or 600 mg/kg/day thereafter to mitigate acute intolerability noted at very young ages in a previous dose range-finding rat study (WIL-779008) and to ensure adequate exposure. 2 Group denominator includes main and recovery animals. 3 Group denominator also includes toxicokinetic animals if sacrificed early or found dead due to CCI . Steady-state exposures (AUC from 0 to 24 hours [AUC0-24]) in rats at the lowest dose (100 mg/kg/day) at which no CCI occurred in the 13-week adolescent rat study were 2.5- to 8- fold greater than that observed in humans at the recommended Phase 2 dose (RP2D; 800 mg twice daily [BID]) from the ongoing Phase 1/2 Study E7438-G000-101. In male juvenile rats, C was not seen at 50 mg/kg/day (AUC(0-24h)=6340 ng•h/mL). A low incidence of CCI CI (2/60) was seen at AUC(0-24h) 18,500-67,200 ng-h/mL and greater for juvenile rats, with higher incidence at AUC(0-24h) 125,000- 290,000 ng-h/mL The first incidence of CCI in juvenile rats occurred at a similar AUC0-24h as the single pediatric patient that developed CCI on Study EZH-102. There have been no cases of CCI in any adult patient given tazemetostat. All patients will be actively monitored for signs or symptoms of abnormal bone formation during the trial. No incidences of new abnormal bone formation have been observed in the ongoing cl...
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Animal Toxicology. The intravenous LD® of sodium tetradecyl sulfate in mice was reported to be 90 ± 5 mg/kg. In the rat, the acute intravenous LD® of sodium tetradecyl sulfate was estimated to be between 72 mg/kg and 108 mg/kg. Purified sodium tetradecyl sulfate was found to have an LD® of 2 g/kg when administered orally by stomach tube as a 25% aqueous solution to rats. In rats given 0.15 g/kg in drinking water for 30 days, no appreciable toxicity was seen, although some growth inhibition was discernible. Manufactured for: Bioniche Pharma U.S.A. Inc. Xxxxxx, XX 00000 Manufactured by Bioniche Teo Xxxxxxx, Xx. Xxxxxx, Xxxxxxx Issued: October 2004 0521L100 Sotradecol Pharmaceutical preparations, namely composition for treatment of varicose veins 76385054 Attached as a part of this Schedule “C” is the applicable Statement of Use, filed by Cumberland Pharmaceuticals, Inc., on October 4, 2005. The Registration Statement is to be provided by Bioniche when available, and will be attached to this Schedule “C.” PTO Form 1553 (Rev 4/2000) OMB Control #0651-0009 (Exp. 06/30/2005) SERIAL NUMBER 76385054 LAW OFFICE ASSIGNED LAW OFFICE 115 NOTICE OF ALLOWANCE YES EXTENSION OF USE NO REQUEST TO DIVIDE NO STANDARD CHARACTERS NO LITERAL ELEMENT SOTRADECOL NAME Cumberland Pharmaceuticals Inc. STREET 000 Xxxxx Xxxxxx Xxxxx, Xxxxx 000 XXXX Xxxxxxxxx XXXXX Xxxxxxxxx ZIP/POSTAL CODE 37203 COUNTRY United States NAME Cumberland Pharmaceuticals Inc. INTERNAL ADDRESS Suite 950 STREET 0000 Xxxx Xxx Xxxxxx XXXX Xxxxxxxxx XXXXX Xxxxxxxxx ZIP/POSTAL CODE 37203 COUNTRY United States PHONE 000-000-0000 FAX 000-000-0000 EMAIL xxx.xxxxxx@xxxxx.xxx NAME Xxxxx X. Xxxxx NAME Xxxxx X. Xxxxx DOCKET NUMBER 604816-000007 INTERNATIONAL GLASS 005 GOODS AND/OR SERVICES KEEP ALL LISTED FIRST USE ANYWHERE DATE 07/25/2005 FIRST USE IN COMMERCE DATE 07/25/2005 SPECIMEN FILE NAME(S) \\TICRS\EXPORT8\IMAGEOUT8\763\850\76385054\xmll\SO U0002.JPG SPECIMEN DESCRIPTION Photograph of label/packaging NUMBER OF CLASSES 1 SUBTOTAL AMOUNT 100 TOTAL AMOUNT 100 SIGNATURE /xxxxx x. xxxxx/ SIGNATORY NAME Xxxxx X. Xxxxx SIGNATORY DATE 10/04/2005 SIGNATORY POSITION Attorney SUBMIT DATE Tue Oct 04 16:20:14 EDT 2005 TEAS STAMP USPTO/SOU-209.149.60.98-2 0051004162014572219-76385 054-250a168c3f03474c4dc8a d72a2c7a87d0a3-DA-288-200 51004161601906958 PTO Form 1553 (Rev 4/2000) OMB Control #0651-0009 (Exp. 06/30/2005) To the Commissioner for Trademarks:

Related to Animal Toxicology

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in xxxx rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

  • Diagnostic procedures to aid the Provider in determining required dental treatment.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • 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.

  • 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.

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Laboratory Testing All laboratories selected by UPS Freight for analyzing Controlled Substances Testing will be HHS certified.

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