Clinical Trial Material definition

Clinical Trial Material means Product and placebo for administration to animals for pre-clinical testing or to humans for clinical testing.
Clinical Trial Material or “CTM” means Licensed Product that is in a finished pharmaceutical dosage form that is (a) suitable for administration and dosing to humans in clinical trials, but (b) not intended for commercial sale (for example, without limitation, in a form that does not include external packaging and package inserts).
Clinical Trial Material means Licensed Product and placebo for administration to humans in a Clinical Trial.

Examples of Clinical Trial Material in a sentence

  • The disposition of all investigational product delivered to a Principal Investigator must be recorded on a subject-by-subject basis by completing the Clinical Trial Material Accountability Log.

  • BlindingAlthough the identity of the syringes will not be revealed, it is recognized that there is a visible difference in the Clinical Trial Material (CTM) in the syringes as well as a difference in the extrusion force among Cingal, Monovisc and triamcinolone hexacetonide (TH) and a difference in volume.

  • Clinical Trial Material Accountability Logs must be kept current and should contain the following information:• Identification of the subject to whom a kit was dispensed including randomization numbers and initials• The date a kit was dispensed to a subject• The date a kit was sent back to Topical Remedy.• The date and quantity of any disposed kits, and the initials of the person who disposed of the kits.

  • For the triamcinolone hexacetonide arm, an ampoule of triamcinolone hexacetonide will be provided by the Sponsor as Clinical Trial Material.

  • In short, Patheon is uniquely capable of developing exactly the right formulation and processes to ensure a product’s future success.Late Development Services• Manufacturing Process Development• Analytical Method Development and Validation• Product Release and Stability Testing• Clinical Trial Material Manufacturing• Primary Packaging• Regulatory Dossier Support• Lifecycle Management Services Commercial Manufacturing A reputation for high quality established over 39 years.Dependable quality.


More Definitions of Clinical Trial Material

Clinical Trial Material means labeled and packaged Sphingosomal Vincristine, Sphingosomal Vinorelbine and/or Sphingosomal Topotecan, and any component(s) thereof used or to be used, in clinical trials.
Clinical Trial Material means any raw materials, parts, or supplies used in the ordinary course of development of a Product for which regulatory approval has not yet been obtained and that are used exclusively for purposes of supporting clinical and preclinical research.
Clinical Trial Material means Product and placebo for administration to humans in the BDSI Trials, Existing Clinical Trials, or Supportive Trials.
Clinical Trial Material means the Licensed Compound in finished dosage form that is used in clinical trials, but not for Commercial sale.
Clinical Trial Material means a Licensed Product or placebo, as applicable, that is in a finished pharmaceutical dosage form that is (a) suitable for administration and dosing to humans in clinical trials, but (b) not intended for commercial sale (for example, in a form that does not include external packaging and package inserts).
Clinical Trial Material means labeled and packaged Sphingosomal Vinorelbine and/or Sphingosomal Topotecan, and any component(s) thereof, used or to be used, in clinical trials.
Clinical Trial Material or “CTM” means a Product that is in a finished pharmaceutical dosage form that is intended and suitable for administration and dosing to humans in Clinical Trials, but not intended for commercial sale (for example, in a form that does not include external packaging).