Banca de DEFESA: AMANDA DE PAULA OLIVEIRA

Uma banca de DEFESA de MESTRADO foi cadastrada pelo programa.
STUDENT : AMANDA DE PAULA OLIVEIRA
DATE: 20/07/2022
TIME: 17:00
LOCAL: Campus Nova Gameleira
TITLE:

VALIDATION OF SYNTHESIS METHODOLOGIES, DEVELOPMENT AND ANALYTICAL QUALITY CONTROL FOR RADIODRUG 18F PSMA - 1007

KEY WORDS:

Radiodrug, Synthesis, Quality Control, Cancer

PAGES: 80
BIG AREA: Ciências Exatas e da Terra
AREA: Química
SUBÁREA: Química Analítica
SPECIALTY: Instrumentação Analítica
SUMMARY:

ABSTRACT Prostate cancer is the second most common type of cancer among men, if detected early the healing rate is almost 100%. Lately, nuclear medicine has become an important tool in the diagnosis and staging of prostate cancer, by using techniques such as PET/CT (Positron Emission Tomography and Computed Tomography). The use of PET tomography allows mapping the distribution of positron emitters administered to the patient, enabling early diagnosis of physiological changes. For that, it must be administered to a radiopharmaceutical whose radionuclide that constitutes it is a positron emitter. The radiopharmaceutical 18F PSMA-1007 ( 18F-labeled Prostate Specific Membrane Antigen), whose positron-emitting radionuclide is 18F, has become a viable target for prostate imaging and therapy, since PSMA, a membrane glycoprotein, is expressed in almost every type of prostate cancers. PSMA has its expression level about 1000 times higher in cancer cells when compared to the physiological levels found in other tissues, this makes PSMA a promising target for detection in imaging tests. The intensity of the accumulation of 18F PSMA-1007 in prostate tumors is positively correlated with other ways of evaluating and detecting prostate cancer, making the diagnosis more assertive. 18F PSMA-1007 can be obtained by a nucleophilic substitution reaction, where 18F reacts with a precursor, its use as a pharmaceutical preparation requires that quality control tests are carried out, which meet the Good Manufacturing Practices established by the regulatory body, in Brazil, ANVISA.

Aiming the production and commercialization of this radiopharmaceutical in the CDTN, an attempt was made to establish the synthesis  and  quality control methodologies for this product . A procedure for the synthesis of the radiopharmaceutical 18F PSMA-1007 was implemented in the TRACERlab FX equipment, viable and capable of being performed according to Good Manufacturing Practices for Medicines. Analytical methodologies were developed and validated to certify complies with the quality control specifications. The analytical methodologies developed in this work in relation to other ones described, have the main advantage of the shorter execution time of the analyses, allowing the radiopharmaceutical to have its quality attested and to be released for use in patients in a shorter period of time.

BANKING MEMBERS:
Presidente - ILDEFONSO BINATTI
Externa ao Programa - JUNIA DE OLIVEIRA ALVES BINATTI
Externa ao Programa - PATRICIA SUELI DE REZENDE
Interno - PATTERSON PATRICIO DE SOUZA