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ANALYSIS OF THE FILES ON GENERIC DRUGS BROUGHT BEFORE THE SPANISH AGENCY OF MEDICINES PERIOD 2000-2002.Author: SANTOS REAL HEIDI DE LOS. Year: 2004. University: COMPLUTENSE DE MADRID [ www.ucm.es]. Place of defense: FACULTAD DE FARMACIA. Place of preparation: FACULTAD DE FARMACIA. Summary: Medicines requiring a permit to be comercializados.La purpose of the authorization is to prevent the uncontrolled use of these products, which can be harmful and pose a risk to public health. To obtain marketing authorization for a drug by the Health Management Spanish, certain procedures must be followed to ensure the registration concession from the authorities after carrying out strict criteria for quality, safety and efficacy information. The aim of this thesis has been to analyze various aspects of generic drugs over the period 2000-2002. Chapter 1. Addresses Spanish law pertaining to this type of medicamentos.Los Chapters 2 and 3 present an analysis detalladode applications for registration of medicines for human use tabled before the Spanish Agency of Medicines, during the study period (2913 records) and authorities (2353 records), deepening the files relating to the generic pharmaceutical specialties. In chapter 4 is a comprehensive analysis of records of registration of generic pharmaceutical specialties, depending on their developments, to analyze - groups terapéuticos-las most frequent causes for which denied dossier registro.Se has sought, thus, to serve as future reference for the industry farmecéutica, with the intent to avoid errors and omissions Frequently in such cases. In Chapter 5 discusses the origin of the raw materials and the manufacturer of the finished product, with the goal of having data on the origin of these manufacturers, both records authorized generics on how denied carrying out an analysis of 1270 records studied to assess the manufacture of generic drugs submitted for registration during that time was purely national or came mostly from abroad.
OPTIMIZING WITH MODIFICATIONS FARMACOTÉCNICAS ARRAY POLIMERICAS. DEVELOPMENT OF ALTERNATIVE FORMULATIONS.Summary: The objective of this dissertation is the optimization of acrylic bone cement through its technical characteristics drug along with the search for possible alternative biodegradable biomaterials, such as tablets and pastes hydrophilic microspheres implantation of hydroxyapatite. The first chapter describes the changes made in cements óseoscomercializados and discusses the impact of these amendments on the porosity, surface morphology and the assignment of these cements farmaco. In the second and third chapter discusses the changes made affecting the thermal properties, mechanical and crystallinity of cements. The fourth chapter describes the cytotoxicity chemistry of cement due to the assignment of monomer that has not reacted in polimerización.Los studies reveal that both the cytotoxicity marketed as modified cements are cytotoxic. Based on the results of toxicity of the previous chapter the last chapter of the work is devoted to the search for other biocompatible materials for repairs and dental care, such as polymers poli-lactic-gliocólico (PLGA) and hidroxiapatitas natural consiguiéndose to obtain these materials formulations they control the transfer of the drug in aqueous medium. PHARMACOKINETICS AND EFFICACY OF OXYTETRACYCLINE AFTER INTRAMUSCULAR ADMINISTRATION IN CATTLE. DEPLETION TISSUESummary: The widespread use of antibiotics in animal production has certainly made a significant benefit to the health and welfare of animals, although in recent years this use has been severely criticized and legal pressures because of the controversy arising between risk and the beneficial effect of these substances farmácologicas. The oxytetracycline by its broad spectrum of bacteria and its high use both preventive and therapeutic, it is in the antibiotic group strongest criticism received. For its possible adverse effect on the health of consumers and their possible failure effectiveness has led us to study in depth the characteristics Pharmacokinetic introducing this drug after administration intramuscularly well as evaluating the effectiveness of treatment and possible presence of residues in tissues intended for consumption. To make the kinetic study were administered two formulations olesas commercial calves (30 mg / kg) intramuscularly in the tables at the neck, plasma samples were taken at different times of sampling and were analyzed by high pressure liquid chromatography effectiveness as a method analytical previously validated. The pharmacokinetic parameters were calculated: Cmax, Tmax, AUC, MRT and T1 / 2, was evaluated bioequivalence of the two specialties used and finally evaluated the therapeutic efficacy of this drug compared to different microorganisms that cause respiratory complex. And for the study of waste, oily formulation was administered intramuscularly (30 mg / kg) to 12 calves were slaughtered and at different tempos (28, 35 y42 days), samples were taken from different target tissues and analyzed for high efficiency liquid chromatography using a previously validated analytical method. And estimated waiting time of this specialty. The results showed that both specialties will fit a profile kinetic formulation delayed and were bioequivalent. The efficacy studies showed that both formulations are effective against Mycoplasma hyopneumoniae and Moraxella bovis. The waiting time was 45.5 days for kidney and 54.6 days for the liver. It was not possible to their calculation in the case of muscle and at the injection site due to the fact that in recent times of sacrifice made yet concentrations were observed above the maximum residue limit. NEW ANALYTICAL METHODOLOGIES FOR THE DETERMINATION OF ANTIHYPERTENSIVE DRUGS USED IN CARDIOVASCULAR THERAPY COMBINED.Author: FERREIROS BOUZAS NEREA. Year: 2006. University: PAÍS VASCO [ www.ehu.es]. Place of defense: FACULTAD DE CIENCIA Y TECNOLOGÍA. Place of preparation: FACULTAD DE CIENCIA Y TECNOLOGÍA.
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