Biologically Active Substance definition

Biologically Active Substance means any product other than Licensed Product which has intrinsic biological or cell stimulatory activity related to the presence of growth factors, such as insulin-like growth factors (e.g., IGF-I, IGF-I etc), transforming growth factor family (e.g. TGF-beta, etc), epidermal growth factor (EGF), fibroblast growth factors (aFGF, bFGF, etc), keratinocyte growth factor (KGF), growth factor like proteins or morphogens. Such product will not include substances or compounds whose primary function is to act as a vehicle for the delivery of PDGF (eg. synthetic bone powder such as hydroxyapatitcs, natural bone powder at bone matrix fibrin glue, collagen, gelatin, or synthetic polymers such as polylatides or polyglycolides).
View Source
Biologically Active Substance means a pharmaceutically active substance that has intrinsic biological or cell stimulatory activity, but not including a substance that acts as a stabilizing agent, excipient or adjuvant or whose primary function is to act as a delivery vehicle.
View Source

Related to Biologically Active Substance

  • Radioactive substance means a substance that emits ionizing

  • Chemical substance means a substance intended to be used as a precursor in the manufacture of a controlled substance or any other chemical intended to be used in the manufacture of a controlled substance. Intent under this subsection may be demonstrated by the substance's use, quantity, manner of storage, or proximity to other precursors or to manufacturing equipment.

  • Controlled substance means a controlled substance in schedules I through V of Section 202 of the Controlled Substances Act (2l U.S.C. 8l2) and as further defined in regulation at 2l CFR l308.ll-l308.l5.

  • Regulated substance means any substance, material or waste the use, generation, handling, storage, treatment or disposal of which is regulated by any local or state government authority, including any of the same designated by any authority as hazardous, genetic, cloning, fetal, or embryonic.

  • Contaminant means any material, substance or waste that is classified, regulated or otherwise characterized under any Environmental Law as hazardous, toxic, a contaminant or a pollutant or by other words of similar meaning or regulatory effect, including any petroleum or petroleum-derived substance or waste, asbestos and polychlorinated biphenyls.