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.
Phase III Study means a controlled clinical study of the Licensed Product that is prospectively designed to demonstrate with statistical significance the efficacy and safety of the Licensed Product for use in a particular indication and that is sufficient to obtain Regulatory Approval to market the Licensed Product in such indication.
Phase III Study means a pivotal study in humans of the efficacy and safety of a Product, which is prospectively designed to demonstrate statistically whether such product is effective and safe for use in a particular indication in a manner sufficient to file an NDA or MAA to obtain regulatory approval to market the product, as further defined in Federal Regulation 21 C.F.R. §312.21(c) and its foreign equivalents.
Examples of Phase III Study in a sentence
Gemcitabine and Oxaliplatin Chemotherapy or Surveillance in Resected Biliary Tract Cancer (PRODIGE 12-ACCORD 18-UNICANCER GI): A Randomized Phase III Study.
Analysis of KRAS/NRAS Mutations in a Phase III Study of Panitumumab with FOLFIRI Compared with FOLFIRI Alone as Second-line Treatment for Metastatic Colorectal Cancer.
Latest news: Teva Announces Positive Results for Phase III Study of Fremanezumab for the Prevention of Chronic Migraine.
Pharmacokinetic (PK), Safety and Efficacy Data on Cohort IIA; youth aged 6-11 from IMPAACT P1066: A Phase I/II Study to Evaluate Raltegravir (RAL) in HIV-1 Infected Youth.
The quality assurance project plan (QAPP), Building Demolition Evaluation Phase III Study – Alternative Asbestos Control Method (December 2007) was developed by to serve as the guide for collecting and analyzing the data from this research effort.
More Definitions of Phase III Study
Phase III Study means a large scale human clinical trial in any country that would satisfy the requirements of 21 C.F.R. 312.21(c) (as amended) (whether or not such trial is for the FDA), but which is not a Phase IV Study.
Phase III Study means a pivotal clinical study in human patients with a defined dose or set of doses of a Clinical Development Candidate that is designed to ascertain the safety and efficacy of (or to otherwise satisfy the requirements of 21 C.F.R. § 312.21(c) or its foreign equivalent with respect to) such Clinical Development Candidate for a particular Cardiovascular Indication, which Phase III Study is conducted for the purpose of enabling the preparation and submission of applications for Regulatory Approval to the competent regulatory authorities in a country of the Territory.
Phase III Study means, in respect of a Sublicensed Product, (a) that portion of the FDA submission and approval process in which expanded clinical studies are conducted to gather the additional information about effectiveness and safety that is need to evaluate the overall benefit-risk relationship of a product as more specifically defined by the rules and regulations of the FDA, including 21 C.F.R. § 312.21(c) or any future revisions or substitutes thereof; or (b) a similar clinical study in any natural jurisdiction other than the United States.
Phase III Study means the conduct of a human study, as described in 21 C.F.R. §312.21(c) and its foreign equivalents, of a Licensed Product.
Phase III Study means any controlled study in humans of the efficacy and safety of a product which is conducted after Phase II Study has been completed and which is prospectively designed to demonstrate statistically whether the product is safe and effective for use in a particular indication and is usually intended to be sufficient to support registration of the Product.
Phase III Study means a Phase III clinical trial as prescribed by applicable FDA regulations, or corresponding regulations of any comparable entity.
Phase III Study means a controlled and lawful study in humans of the efficacy and safety of a product, which is prospectively designed to demonstrate statistically whether such product is effective and safe for use in a particular indication in a manner sufficient to file an NDA to obtain regulatory approval to market the product, as further defined in 21 C.F.R. § 312.21(c) (or the foreign equivalent thereof).