Release Date Request Code Change Type NCI Code CDISC Term Type CDISC Codelist (Short Name) CDISC Codelist (Long Name) Change Summary Original New 6/28/2013 32766 II C42887 Definition CDASH-CMDOSFRM Concomitant Medication Dose Form Remove attribution from end of definition. A product that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols). (NCI) A product that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols). 6/28/2013 32766 II C42887 Definition CDASH-EXDOSFRM Exposure Dose Form Remove attribution from end of definition. A product that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols). (NCI) A product that is packaged under pressure and contains therapeutically active ingredients that are released upon activation of an appropriate valve system; it is intended for topical application to the skin as well as local application into the nose (nasal aerosols), mouth (lingual aerosols), or lungs (inhalation aerosols). 6/28/2013 32766 II C42934 Definition CDASH-CMDOSFRM Concomitant Medication Dose Form Remove attribution from end of definition. A semisolid (1) dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion (2). A gel may contain suspended particles. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: A colloidal dispersion is a system in which particles of colloidal dimension (i.e., typically between 1 nm and 1 micrometer) are distributed uniformly throughout a liquid. (NCI) A semisolid (1) dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion (2). A gel may contain suspended particles. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: A colloidal dispersion is a system in which particles of colloidal dimension (i.e., typically between 1 nm and 1 micrometer) are distributed uniformly throughout a liquid. 6/28/2013 32766 II C42934 Definition CDASH-EXDOSFRM Exposure Dose Form Remove attribution from end of definition. A semisolid (1) dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion (2). A gel may contain suspended particles. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: A colloidal dispersion is a system in which particles of colloidal dimension (i.e., typically between 1 nm and 1 micrometer) are distributed uniformly throughout a liquid. (NCI) A semisolid (1) dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion (2). A gel may contain suspended particles. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: A colloidal dispersion is a system in which particles of colloidal dimension (i.e., typically between 1 nm and 1 micrometer) are distributed uniformly throughout a liquid. 6/28/2013 32766 II C42966 Definition CDASH-CMDOSFRM Concomitant Medication Dose Form Remove attribution from end of definition. A suspension or emulsion, semisolid (1) dosage form, usually containing < 20% water and volatiles (2) and > 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: Percent water and volatiles are measured by a loss on drying test in which the sample is heated at 105 degrees C until constant weight is achieved. (NCI) A suspension or emulsion, semisolid (1) dosage form, usually containing < 20% water and volatiles (2) and > 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: Percent water and volatiles are measured by a loss on drying test in which the sample is heated at 105 degrees C until constant weight is achieved. 6/28/2013 32766 II C42966 Definition CDASH-EXDOSFRM Exposure Dose Form Remove attribution from end of definition. A suspension or emulsion, semisolid (1) dosage form, usually containing < 20% water and volatiles (2) and > 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: Percent water and volatiles are measured by a loss on drying test in which the sample is heated at 105 degrees C until constant weight is achieved. (NCI) A suspension or emulsion, semisolid (1) dosage form, usually containing < 20% water and volatiles (2) and > 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes. Note 1: A semisolid is not pourable; it does not flow or conform to its container at room temperature. It does not flow at low shear stress and generally exhibits plastic flow behavior. Note 2: Percent water and volatiles are measured by a loss on drying test in which the sample is heated at 105 degrees C until constant weight is achieved. 6/28/2013 32766 II C42968 Definition CDASH-CMDOSFRM Concomitant Medication Dose Form Remove attribution from end of definition. A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms Extended Release Film and System. (NCI) A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms Extended Release Film and System. 6/28/2013 32766 II C42968 Definition CDASH-EXDOSFRM Exposure Dose Form Remove attribution from end of definition. A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms Extended Release Film and System. (NCI) A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms Extended Release Film and System. 6/28/2013 32766 II C42993 Definition CDASH-CMDOSFRM Concomitant Medication Dose Form Remove attribution from end of definition. A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature. (NCI) A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature. 6/28/2013 32766 II C42993 Definition CDASH-EXDOSFRM Exposure Dose Form Remove attribution from end of definition. A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature. (NCI) A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature. 6/28/2013 32766 II C42994 Definition CDASH-CMDOSFRM Concomitant Medication Dose Form Remove attribution from end of definition. A liquid dosage form that contains solid particles dispersed in a liquid vehicle. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. (FDA) A liquid dosage form that contains solid particles dispersed in a liquid vehicle. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. 6/28/2013 32766 II C42994 Definition CDASH-EXDOSFRM Exposure Dose Form Remove attribution from end of definition. A liquid dosage form that contains solid particles dispersed in a liquid vehicle. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior. (FDA) A liquid dosage form that contains solid particles dispersed in a liquid vehicle. Note: A liquid is pourable; it flows and conforms to its container at room temperature. It displays Newtonian or pseudoplastic flow behavior.