Tolerability definition

Tolerability means adverse drug experiences which are unpleasant to such an extent that they can materially and adversely affect market potential or market penetration of a Product, but which do not necessarily require discontinuation of drug therapy.
Tolerability means the absence of adverse experiences, other than those that are Safety-related experiences, associated with administration of a drug to patients that such patients, or their physicians, deem unpleasant to an extent that can materially and adversely affect market potential or market penetration of a Collaboration Product.
Tolerability means adverse drug experiences which are unpleasant to ------------ such an extent that they can materially and adversely affect market potential or market penetration of a Collaboration Compound or Collaboration Product, but which do not necessarily require discontinuation of drug therapy. (The information below marked by ***** has been omitted by a request for confidential treatment. The omitted portion has been separately filed with the Commission.)

Examples of Tolerability in a sentence

  • A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of BA058 in Healthy Postmenopausal Women ( Pending FDA Approval) Protocol Number: BA058-05-001 The study will be designed to: · Determine the safety and tolerability of multiple subcutaneous doses of BA058 in healthy postmenopausal women.

  • The objective of the Phase la study is to provide preliminary information on Safety, Tolerability and PK of ER-306323.

  • Study Evaluating Safety, Tolerability and Efficacy of YM150 in Subjects With Acute Coronary Syndromes (RUBY-1).

  • The Performance Condition is satisfied only if the press release announcing top line results from the Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis (“Press Release”) is issued on or before June 30, 2024 or such other later date as is determined by the Board or the Committee (such date, the “Press Release Deadline”).

  • The self-assessment will be based on a 5-point Likert scale - Subject Tolerability Scale (Appendix A).

  • The Clinical Study is titled “A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BLU-554 in Patients with Hepatocellular Carcinoma and Cholangiocarcinoma” (NCT02508467).

  • Name of Investigational Product: ALKS 8700 Name of Active Ingredient: ALKS 8700 Title of study: A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate Investigators: This study will be a multicenter study.

  • As of the Execution Date, ▇▇▇▇▇ is conducting a Clinical Trial with respect to the Licensed Product under a protocol entitled, “A Phase 2a, Randomized, Open-Label Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 702843 Administered to Patients with Phlebotomy Dependent Polycythemia ▇▇▇▇ (PD-PV)” (the “Ongoing Clinical Trial”).

  • Draft and Final reports of the Tolerability study and the Feasibility study.

  • Controlled Study of the Efficacy and Tolerability of Veliparib in Combination with Paclitaxel Carboplatin-Based Chemoradiotherapy Followed by Veliparib and Paclitaxel/Carboplatin Consolidation in Subjects with Stage III”, which may be amended from time to time in writing by AbbVie (the “Protocol”); and • Studie se má provádět podle protokolu č.


More Definitions of Tolerability

Tolerability means adverse drug experiences which are unpleasant to such an extent that they can affect, in the Parties' mutual judgment (which judgment shall be based on information available at that time and on the Parties' mutual experience), market potential or market penetration but which do not necessarily require discontinuation of drug therapy.
Tolerability means adverse drug experiences which are unpleasant to such an extent that they can materially and adversely affect

Related to Tolerability

  • Vulnerability means a weakness of an asset or mitigation that can be exploited by one or more threats.

  • Stability (7) means the standard deviation (1 sigma) of the variation of a particular parameter from its calibrated value measured under stable temperature conditions. This can be expressed as a function of time.

  • Permeability of a space means the ratio of the volume within that space which is assumed to be occupied by water to the total volume of that space.

  • Security Vulnerability means a flaw or weakness in system security procedures, design, implementation, or internal controls that could be exercised (accidentally triggered or intentionally exploited) and result in a security breach such that data is compromised, manipulated or stolen or the system damaged.

  • Tolerance means a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time.