Phase III Study definition

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 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).

Phase III Study means a controlled pivotal clinical study of the Licensed Product that is prospectively designed to demonstrate in a statistically significant manner in the intended patient population whether the Licensed Product is effective and safe for use in a particular indication and prospectively designed in a manner sufficient to obtain regulatory approval in the event of positive results (whether alone or together with other such Phase III Studies).

Examples of Phase III Study in a sentence

• Xxxx seeks to enter into a General Services Agreement (the “GSA”) with Quintiles, Inc., a North Carolina corporation and an affiliate of PharmaBio (“Quintiles”), whereby Quintiles will perform services relating to “A Phase III Study of Toluidine Blue Rinse as an Aid to the Detection of Locally Recurrent or New Primary Oral Cavity Cancers and Cancer In Situ (Protocol ZIL-301)”(the “Project”).

• If an NDA is filed after the end of a Phase II Study for a Licensed Compound, then the Phase III Study milestone event shall be deemed achieved as of the date of such filing.

• The Institution will permit the Investigator to conduct the clinical research study entitled SPARTAN: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer (the “Study”), bearing protocol number ARN-509-003, as may be amended from time to time (the “Protocol”).

• Promptly following the availability of (a) top-line results from the first Phase II Study of a Licensed Product and (b) top-line results from the first Phase III Study of a Licensed Product, Licensee shall notify Licensor and shall provide all then available data, results and reports of such studies, and Licensor shall also provide Licensor three months’ prior written notice of the date it expects to file the first MAA for a Licensed Product.

• Aptiv and Client desire that Aptiv provide certain Services with respect to a Phase I/II Advanced Myeloid Malignancy study, (the "Study") for the study of the drug 225AC-HuM195 ("Study Drug") as set out in the Protocol titled: A Phase I/II Study on the Safety and Efficacy of 25AC-HuM195 in Patients with Advanced Myeloid Malignancies, which is incorporated herein by reference.

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, as to a particular product for a particular indication, a controlled and lawful study in humans of the safety and efficacy of such product for such indication, which is prospectively designed to demonstrate statistically whether such product is safe and effective for use in such indication in a manner sufficient to file a Drug Approval Application to obtain Regulatory Approval to market and sell that product for the indication under investigation in such study.

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 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, 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 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.