Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.
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 I Clinical Study means, as to a specific Licensed Product, a study of such product in humans designed to satisfy the requirements of 21 C.F.R. § 312.21(a), as amended from time to time, or the corresponding regulation in jurisdictions other than the United States.
Examples of Phase I Clinical Study in a sentence
Phase I Clinical Study of ZYAN1, A Novel Prolyl-Hydroxylase (PHD) Inhibitor to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Oral Administration in Healthy Volunteers.
On December 22, 2014, the Company received clearance from Health Canada to conduct a Phase I Clinical Study with TKM-HBV, which utilizes Arcturus’ UNA technology.
Anhui Zhifei Longcom Biologic Pharmacy Co Ltd, The Second Affiliated Hospital of Chongqing Medical University, and Beijing Chao Yang Hospital, Phase I Clinical Study of Recombinant Novel Coronavirus Vaccine.
Drevs, J., et al., Phase I Clinical Study of AZD2171, an Oral Vascular Endothelial Growth Factor Signaling Inhibitor, in Patients With Advanced Solid Tumors.
Total extracorporeal arteriovenous carbon dioxide removal (AVCO2R) in acute respiratory failure: A Phase I Clinical Study.
More Definitions of Phase I Clinical Study
Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is gaining evidence of the safety and tolerability of, and information regarding pharmacokinetics and potential pharmacological activity in a target patient population, as described in 21 C.F.R.§ 312.21(a) (as amended or any replacement thereof), or a similar clinical study prescribed by the NMPA or other Regulatory Authority in a country other than the United States.
Phase I Clinical Study means a clinical study conducted in accordance with good clinical practice ("GCP") in a small number of healthy volunteers or patients designed or intended to establish an initial safety profile, pharmacodynamics or pharmacokinetics of Product.
Phase I Clinical Study means a study of a Licensed Product in human subjects with the endpoint of determining initial tolerance, safety or pharmacokinetic information in single dose, single ascending dose, multiple dose and/or multiple ascending dose regimens.
Phase I Clinical Study means (a) in connection with obtaining Marketing Authorization Approval in the United States, the first Clinical Study conducted in human volunteers or patients to obtain preliminary information on a Licensed Product’s safety, tolerability, pharmacodynamic activity, pharmacokinetics, drug metabolism and mechanism of action, as well as early evidence of effectiveness if possible, as more fully defined in 21 C.F.R. § 312.21(a), as may be amended or (b) in connection with obtaining Marketing Authorization Approval in any other jurisdiction, the equivalent of any such Clinical Study in such other country or jurisdiction.
Phase I Clinical Study means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(a).
Phase I Clinical Study means any Clinical Trial(s) the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, that would satisfy the requirement of 21 C.F.R. § 312.21(a), or its foreign equivalent, as may be amended from time to time, or any analogous Clinical Trial described or defined in Applicable Laws.
Phase I Clinical Study means that portion of the Development program that generally provides for the first introduction into humans of the Compound with the primary purpose of determining safety, metabolism and pharmacokinetic properties and clinical pharmacology of the CTM Product in healthy patients, and generally consistent with 21 CFR §312.21(a), or its foreign equivalent in non-U.S. countries of the Territory. A Phase I Clinical Study can comprise a Phase Ia clinical study and a Phase Ib clinical study. A Phase Ia clinical study is a study performed in healthy humans. A Phase Ib clinical study is a study performed in human patients.