Phase I Clinical Trial definition
Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.
Phase I Clinical Trial means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(a).
Phase I Clinical Trial means the initial introduction of a Licensed Product as an investigational new drug into humans as required in 21 C.F.R. § 312, designed to determine the metabolism and pharmacologic actions of the Licensed Product in humans, the side effects associated with increasing doses and, if possible, to gain early evidence on effectiveness, and also includes studies of drug metabolism, structure-activity relationships and mechanism of action in humans.
Examples of Phase I Clinical Trial in a sentence
Morphosys has chosen six (6) Targets, but is – under the Morphosys License Agreement – still entitled to replace up to four (4) Targets that are abandoned prior to start of a Phase I Clinical Trial during the term of the Morphosys License Agreement.
More Definitions of Phase I Clinical Trial
Phase I Clinical Trial means a clinical trial of a Product generally consistent with 21 C.F.R. §312.21(a) or equivalent trial outside of the United States.
Phase I Clinical Trial means any clinical study conducted on sufficient numbers of human subjects to establish that a pharmaceutical or biological product is reasonably safe for continued testing and to support its continued testing in Phase II Clinical Trials. “Phase I Clinical Trial” shall include without limitation any clinical trial that would satisfy requirements of 21 C.F.R. § 312.21(a).
Phase I Clinical Trial means the initial clinical testing of the Product in humans (first-in-humans study) with the intention of gaining a preliminary assessment of the safety of the Product.
Phase I Clinical Trial means a clinical trial as defined in 21 C.F.R. 312.21(a), as may be amended from time to time, or any foreign equivalent thereto.
Phase I Clinical Trial means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(a) or a similar clinical trial as defined by the Regulatory Authorities.
Phase I Clinical Trial means a human clinical trial, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients as required in 21 C.F.R. §312, or a similar clinical study prescribed by the regulatory authorities in a country other than the United States.
Phase I Clinical Trial means, as to a specific Licensed Product, a lawful study 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 as required for Regulatory Approval.