FDA Data Element Number. Pending.
CDER Data Element Number. C-DRG-0932
Data Element Name. SPLIMAGE
Description. The SPLIMAGE is comprised of two or more views of the same dosage form of the product; in most cases this should represent front and back views of the dosage form, but occasionally additional views might be needed in order to capture all of the important physical characteristics of the dosage form. Any imprint and/or symbol should be clearly identifiable, and the viewer should not normally need to rotate the image in order to read it. Images that are submitted with SPL should be included in the same directory as the SPL file.
The SPLIMAGE should be collected as follows:
All images are created and photographed using a standard 6x4 grid. A millimeter ruler that is white with black markings should be included along the bottom horizontal and right vertical axes of the grid. Dosage forms are attached to this grid showing their front and back, producing a complete image. When positioning the dosage form on the grid, place the back of the dosage form 5 mm from the bottom horizontal and right vertical axes of the grid. Then place the front of the dosage form 5 mm from the bottom horizontal axis of the grid and 5 mm from the edge of the back of the dosage form. This will result in the front view of the dosage form on the left and the back view of the dosage form on the right, and both dosage forms together being superior to the bottom horizontal axis of the grid and to the left of the right vertical axis of the grid.
After the dosage form has been photographed, the entire photograph is imported into photo editor software. The image of each dosage form, front and back, is cropped and adjusted to match the grid so that the images are the exact size of the dosage forms.
Use a 1" x 1 ¾" crop size for all dosage form images. This uniformly standardizes all dosage form images.
Use a self color-calibrating monitor to registering the exact colors of the dosage forms.
The background is changed to a standard grey (RGB=138;138;138). Experience has shown that the use of this standard color optimizes the display of the image.
The resolution is changed to 305 dpi. It is then also saved as a .jpg for web usage.
FDA Specifications. No further specifications.
CDER Specifications. No further specifications.
FDA Approved Date. 30-JUN-2005
CDER Approved Date. 30-JUN-2005
FDA Revised Date.
CDER Revised Date.
Data Values. Not applicable.