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 labeled and packaged Sphingosomal Vincristine, Sphingosomal Vinorelbine and/or Sphingosomal Topotecan, and any component(s) thereof used or to be used, in clinical trials.

Examples of Clinical Trial Material in a sentence

• If POZEN elects to continue any ongoing studies using Sumatriptan or Clinical Trial Material supplied by GSK, GSK will continue to support CMC aspects of the respective IND with appropriate documentation in order to allow completion of any such studies.

• The Parties agree that CEPI may delegate the management of the Ready Reserve of Clinical Trial Material to WHO or another CEPI designee, at its discretion.

• Such Ready Reserve of Clinical Trial Material may be used for further clinical trials, to advance product development and for emergency use subject to obtaining all necessary regulatory approvals and consents, in each case in emergency situations based on national or international guidance (such as from WHO) or in such other manner, in each case as CEPI may reasonably determine.

• Fresenius will notify TransMedics prior to the destruction of any PRODUCT designated as Clinical Trial Material involved in clinical trials in which TransMedics was engaged.

• CEPI may instruct and fund Awardee to undertake the manufacturing and maintenance of a Ready Reserve of Clinical Trial Material through an additional Work Package, which may include doses from consistency batches if so directed by CEPI.

More Definitions of Clinical Trial Material

Clinical Trial Material means Licensed Product and placebo for administration to humans in a Clinical Trial.

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 the Licensed Compound in finished dosage form that is used in clinical trials, but not for Commercial sale.

Clinical Trial Material means Product and placebo for administration to humans in the BDSI Trials, Existing Clinical Trials, or Supportive Trials.

Clinical Trial Material or “CTM” means a Product that is in a finished pharmaceutical dosage form that is intended for administration and dosing to humans in clinical trials.

Clinical Trial Material or “CTM” means a batch of one or more Candidates or Products, as applicable, Manufactured to cGMP by or on behalf of either Party for Clinical Trials.

Clinical Trial Material means the Product manufactured by SurModics to support Clinical Trials.