Phase 1b Clinical Trial definition

Phase 1b Clinical Trial means a human clinical trial of a compound, the principal purpose of which is a further determination of safety and pharmacokinetics (including exploration of trends of a biomarker-based or clinical endpoint-based efficacy relationship to dose which are not designed to be statistically significant) of the compound whether or not in combination with concomitant treatment after an initial Phase 1a Clinical Trial, prior to commencement of Phase 2 Clinical Trials or Phase 3 Clinical Trials, and which provides (itself or together with other available data) sufficient evidence of safety to be included in filings for a Phase 2 Clinical Trial or a Phase 3 Clinical Trial with Regulatory Authorities, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

Phase 1b Clinical Trial means a Phase 1 Clinical Trial in the target patient population that is designed to establish safety and immunogenicity, which may also be designed to establish an initial indication of efficacy.

Phase 1b Clinical Trial means a study in humans which provides for the first introduction of a pharmaceutical product into patients having the disease of interest with the primary purpose of determining safety, metabolism and pharmacokinetic properties and clinical pharmacology of such product, in a manner which is consistent with U.S. 21 C.F.R. § 312.21(a) or its foreign equivalents.

Examples of Phase 1b Clinical Trial in a sentence

• Amyloid PET Screening for Enrichment of Early-Stage Alzheimer Disease Clinical Trials: Experience in a Phase 1b Clinical Trial.

• CohBar Announces First Subjects Dosed in its Phase 1b Clinical Trial for CB4211 Under Development for NASH and Obesity.

• Immune and Tumor Genome Signatures Associated with Response to Radiotherapy and Chk-1 Inhibition in a Phase 1b Clinical Trial for Patients with Head and Neck Squamous Cell Carcinoma‌C.A. Clark,1 D.

• The outcomes of this second study were published in the Clinical and Vaccine Immunology (Vitetta et al., 2012, Recombinant Ricin Vaccine Phase 1b Clinical Trial, Clin.

• President and Governance Manager positions as recommended above) to help provide continuity and institutional knowledge to the Board.38 In addition, most institutions rely heavily on training and orientation of new Board members to help bring them up to speed on governance procedures as well as the substantive issues facing the Board.

More Definitions of Phase 1b Clinical Trial

Phase 1b Clinical Trial means a clinical trial of a pharmaceutical product into infected patients with the primary purpose of determining safety, efficacy, metabolism, pharmacokinetic properties and clinical pharmacology of such product.

Phase 1b Clinical Trial means, as to a specific Licensed Product, a human clinical trial in patients in any country that is intended as a study of such product designed to satisfy the requirements of 21 C.F.R. § 312.21(a) in the United States, as amended from time to time, or the corresponding regulation in jurisdictions other than the United States.

Phase 1b Clinical Trial means a clinical trial, or arm thereof, of an investigational product in patients (a) with the primary objective of characterizing its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in 21 C.F.R. 312.21(a), as amended from time to time, or a comparable clinical trial prescribed by the relevant Regulatory Authority in a country other than the United States and (b) with the additional purpose of identifying a recommended dose for a Phase 2 Clinical Trial or Pivotal Clinical Trial based on the review of the maximum tolerated dose during the dose escalation phase together with additional data and safety considerations obtained during the expansion phase.

Phase 1b Clinical Trial means a pilot human clinical trial usually conducted in patients diagnosed with the disease, or condition for which the study drug is intended, who demonstrate some biomarker, surrogate, or possible clinical outcome.

Phase 1b Clinical Trial means a multiple ascending dose (“MAD”) Phase 1 Clinical Trial of a pharmaceutical product, the principal purpose of which is a further determination of safety, pharmacokinetic, and pharmacodynamic (i.e., measurement of plasma HCV RNA) parameters of the pharmaceutical product in patients.

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Phase 1b Clinical Trial means a human clinical trial of a product, [**] prior to commencement of Phase 2 Clinical Trials or Registration-Enabling Clinical Trial, and which provides [**]. For clarity, a Phase 1b Clinical Trial [**].