Bridging Study definition

Bridging Study means an additional Clinical Trial consisting of up to fifty (50) patients from the Territory that allows extrapolation of a foreign pivotal data package to support Regulatory Approval of such Licensed Product in the Territory.

Bridging Study means a supplemental Clinical Trial of a Licensed Product conducted in Japan that is designed to (a) allow extrapolation of pivotal data obtained from a Registrational Clinical Trial within the Arcus Know-How that, in TAIHO’s good faith opinion, did not include sufficient number of Japanese (or other acceptable Asian) patients to obtain Marketing Approval for such Licensed Product by Japanese Regulatory Authorities based solely on the Arcus Know-How and (b) generate all additional clinical data that, along with data within the Arcus Know-How, will be sufficient to obtain Marketing Approval for such Licensed Product in Japan.

Bridging Study means the Clinical Trial conducted [ * ] as described in Schedule 2.1 as such study may be modified from time-to-time as part of the Development Plan in accordance with Section 2.4.3.

Examples of Bridging Study in a sentence

• Dilated Cardiomyopathy Bridging Study – Orodispersible Minitablets of Enalapril in Children with Heart Failure due to Dilated Cardiomyopathy (DCM) (WP8) Heart failure secondary to dilated cardiomyopathy is a relatively rare disease in children, while the prognosis is guarded.

• Created on: August 16, 2010 Sponsor: RADIUS Title: A 7-Day Dermal Bridging Study in [*] Study Number: 20001926 Xxxxxxx River Facility: Ohio Compliance: GLP Species/Strain: [*] Dose Formulation Preparation (assumes basic dose preparation): Test material to be dispensed as received; no samples obtained.

• Study # 20001926 Title: A 7-Day Dermal Bridging Study in [*] (Reference scope of work dated: 06-Aug-2010) $ 49,900 In order to minimize the impact of study delays and cancellations for all sponsors, Xxxxxxx River allocates resources at the time a signed Letter of Payment Authorization is received.

More Definitions of Bridging Study

Bridging Study means a human clinical trial in any country acceptable to FDA approval using the Vaccine, that is designed so that the results can be used to support initiation of the Definitive Clinical Trial (as defined hereinafter) with the Vaccine as the next step in the clinical program under the Development Plan and to support the acceptance by FDA of prior relevant preclinical and clinical study results in the further course of the Vaccine development.

Bridging Study means […***…] It is understood that a Bridging Study shall not include […***…].

Bridging Study means any clinical trial conducted in a country to provide clinical data on safety, efficacy, dosage, and dose regimen to permit the extrapolation of foreign clinical data to the population in such country or in relation to Regulatory Approvals or secondary manufacturing approvals in such country.

Bridging Study means one or more subjects undertaken on a non-award basis by an overseas trained professional seeking to meet the formal requirements for entry into their profession in Australia. An Assessment Statement from the relevant professional body, recognised by the Department of Industry, Innovation, Science, Research and Tertiary Education (DIISRTE), is required to classify study as bridging study.

Bridging Study means the bridging study (TB016A1) described in the Overall Development Plan.

Bridging Study shall have the meaning set forth in Article 3.4.3 (b).

Bridging Study means the investigation of agreement between two methods generally requiring re-testing of all available clinical samples from a pivotal or phase 3 study in the ​ ​ ​ method to which the sponsor wishes to transition and requiring a high degree of concordance of results from the new method in comparison to the original method to be conducted in accordance with the Project Plan and the bridging study protocol developed by IVS and approved by APR.