Safety Target definition

Safety Target means a mammalian orthologue of a Candidate Target or Pursued Disclosed Target [ * ] BMS Compound [ * ] (a) was identified by or on behalf Exelixis pursuant to work under the Mode of Action Program [ * ] Candidate Target or Pursued Disclosed Target [ * ].
Sample 1Sample 2
Safety Target means a mammalian orthologue of a [ * ] (a) was identified by or on behalf Exelixis pursuant to work under the Mode of Action Program [ * ].
Sample 1Sample 2
Safety Target means the Total Incident Recordable Rate (TRIR) as calculated by the U.S. Occupational Safety and Health Administration for the Plan Year.
Sample 1

Examples of Safety Target in a sentence

  • The MPO worked with KYTC and INDOT to develop an acceptable methodology for setting the Safety Target.

  • Fresno COG's Safety Target Subcommittee meets a few times each year to discuss regional traffic safety and sets federal safety performance targets.

  • The purpose of this scheme is to provide a positive reminder of our Safety Target of NIL ACCIDENTS and to reward all eligible members of the factory crew if this can be achieved.

  • The Federal Highway Administration, which works with the State DOTs, has provided a helpful resource, see FHWA Safety Target Coordination Report September 2016.

  • In addition, the MPO hosted the State Safety Engineers Meeting on November 12, a FHWA Safety Target Setting Workshop November 13-14, the 2019 Vision Zero Walk of Silence on November 15, and the FHWA National Vision Zero MPOs Peer Exchange November 20-21.

  • ACTION ITEM: Performance Measure 1 (PM1) Safety Target Setting (PO)2.

  • Further selection from the remaining ranked proposals is in terms of their relative scores, respecting the minimum number of IPs for a) and b).Call ICT call 4 Objective IST-2009.5.2: ICT for Patient Safety Target outcomesa) ICT for safer surgery: Innovative ICT based tools for training, pre-operative planning, and computer-aided surgical interventions.

  • It also indicates that there is a distinct flattening of the curve at around 1.0E-04 indicating the region of the optimal Safety Target and achieving greater risk reduction than this value is likely to satisfy ALARP principles.

  • Approval of the FAMPO Highway Safety Target Setting Letter (ACTION ITEM) d.

  • Status: As stated under Safety Target Setting findings, MDOT is committed to setting goals consistent with FHWA guidelines, and is working with OHSP to develop common Michigan 2018 goals for fatality frequency, fatality rate, and serious injury frequency.


More Definitions of Safety Target

Safety Target means a mammalian orthologue of a Candidate Target or Pursued Disclosed Target [ * ] BMS Compound [ * ] (a) was
Sample 1

Related to Safety Target

  • Yearly (1/Year) sampling frequency means the sampling shall be done in the month of September, unless specifically identified otherwise in the effluent limitations and monitoring requirements table.

  • Yearly (1/Year) sampling frequency means the sampling shall be done in the month of September, unless specifically identified otherwise in the effluent limitations and monitoring requirements table.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • KPI Target means the acceptable performance level for a KPI as set out in each KPI;

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Soft Target means a target that will suffer minimum damage and cause minimum damage to the subject vehicle in the event of a collision.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Semi-annual (2/Year) sampling frequency means the sampling shall be done during the months of June and December, unless specifically identified otherwise.

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Semi-annual (2/Year) sampling frequency means the sampling shall be done during the months of June and December, unless specifically identified otherwise.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Quarterly (1/Quarter) sampling frequency means the sampling shall be done in the months of March, June, August, and December, unless specifically identified otherwise in the Effluent Limitations and Monitoring Requirements table.