Phase I Studies definition

Phase I Studies means that portion of the U.S. Development --------------- Plan, ROW Development Plan or Development relating to each Collaboration Product which provides for the first introduction into humans of such Collaboration Product including small scale clinical studies conducted in normal volunteers or patients to obtain information on such Collaboration Product's safety, tolerability, pharmacological activity, pharmacokinetics, drug metabolism and mechanism of action, as well as early evidence of effectiveness, as more fully defined in 21 C.F.R. (S) 312.21(a).

Phase I Studies means that portion of the clinical development program which provides for the first introduction into humans of a Product including small scale clinical studies conducted in normal volunteers or patients to get information on Product safety.

Phase I Studies means the first clinical studies conducted in human volunteers or patients (e.g. patients with hypertension or diabetes) to obtain preliminary information on a Product’s safety, tolerability, pharmacodynamic activity, pharmacokinetics, drug metabolism and mechanism of action, as well as early evidence of effectiveness if possible, with respect to (i) the United States, as more fully defined in 21 C.F.R. § 312.21(a), as may be amended; or (ii) the equivalent of such a clinical study for submission to the EMEA; or (iii) equivalent submission in such other country or jurisdiction.

Examples of Phase I Studies in a sentence

• The CAISO’s Cluster 8 Phase I Studies, which will be finalized in December 2015, may indicate whether elements of Coolwater-Lugo will be needed to accommodate new generation that comes into the CAISO queue by the end of April 2015.

• First-in-Human Phase I Studies of PRS-080# 22, a Hepcidin Antagonist, in Healthy Volunteers and Patients with Chronic Kidney Disease Undergoing Hemodialysis.

• Once the IC posts the required LOCs following the Phase I Studies, the ISO would start work and would provide a draft Accelerated Process Study to the IC within 120 days with a +/- 20% cost estimate.

• METERINGThe IC did not provide SCE a detailed one-line diagram prior to the Phase I Studies that shows theGenerating Facility’s proposed metering configuration (“metering one-line”).

• Benign Prostatic Hyperplasia (BPH), Relief of Lower Urinary Tract Symptoms (LUTS): Phase I Studies Promising safety and feasibility of the TULSA-PRO® to relieve Lower Urinary Tract Symptoms (“LUTS”) associated with BPH has been demonstrated in two Phase I studies showing improvements in IPSS comparable to modern minimally invasive surgical therapies8.

More Definitions of Phase I Studies

Phase I Studies means the first clinical studies conducted in human volunteers or patients (e.g. patients with Alzheimer’s Disease or another central nervous system disorder) to obtain preliminary information on a Product’s safety, tolerability, pharmacodynamic

Phase I Studies means that portion of the Development Plan or Development relating to each Alliance Product which provides for the first introduction into humans of such Alliance Product including small scale clinical studies conducted in normal volunteers to obtain information on such Alliance Product's safety, tolerability, pharmacological activity, pharmacokinetics, drug metabolism and mechanism of action, as well as early evidence of effectiveness.

Phase I Studies means pilot efficacy studies described in Appendix B hereto ("Phase I Studies") to be conducted by Company.

Phase I Studies means human safety studies aiming at generating sufficient safety data to allow initiation of full scale Phase II patient studies.

Phase I Studies. As to a specific Licensed Product, one or more controlled and lawful studies in humans, the principal purpose of which is a preliminary determination of safety of the Licensed Product for its intended use in healthy individuals or patients to support its continued testing in similar clinical trials prescribed by the FDA or any relevant foreign regulatory authority.

Phase I Studies means the initial introduction of the Product

Phase I Studies means the initial introduction of the Product --------------- into humans to determine its metabolism and pharmacologic actions in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness, as prescribed by applicable FDA regulations (or equivalent regulations of the FDA-equivalent regulatory authority in the Territory).