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1
tesis de grado
This report on pre-professional practices was carried out with the objective of evaluating the registration and re-registration processes for obtaining sanitary registration in a national drugstore, submitted through the Single Window of Foreign Trade (VUCE) from April 2017 - April 2018, the Information processing was represented by graphic data and tables, evidencing as main feature the breach in the evaluation time and the use of the regulations in force in our country, which despite clear and defined provisions are not applied in a homogeneous manner by of evaluators resident in the General Directorate of Drugs, Supplies and Drugs, generating a delay both in the evaluation of dossiers and in the approval of the product. That is why it is necessary to evaluate the time it takes to review a dossier and therefore the issuance of the respective directive resolution for different products....
2
tesis de grado
The objective of the present investigation was to compare the dissolution profiles between the formulations of carbamazepine multifuente of 200mg and TEGRETOL 200 mg as a reference. In the dissolution test, 12 tablets of each formulation were used for the media: 0.1 N HCl pH 1.2; Buffer acetate pH 4.5 and Buffer phosphate pH 6.8; using the dissolution equipment (pallets), 75 rpm, volume 900 mL, temperature 37 ºC +/- 0.5 ºC. The concentrations were determined from standard curves previously elaborated. The percentage dissolution data were analyzed using the independent model method to compare the dissolution profiles of the products by calculating the similarity factor (ƒ2). It was observed that ƒ2 is between the 50-100 range, a specification established by the Food and Drug Administration (FDA), to indicate similarity between two profiles. The values of ƒ2 found for multifuente A we...