biostudies-literatureChauvierre CANRFP7 HealthE699https://www.ebi.ac.uk/biostudies/studies/S-EPMC6949921biostudies-literatureUnknown17(12)The adhesion molecule P-selectin is present on the cell surface of both activated endothelium and activated platelets. The present study describes the pharmaceutical development, safety evaluation, and preclinical efficacy of a micro-dosed radiotracer. The macromolecular nanoscale assembly consisted of a natural compound made of a sulfated fucose-rich polysaccharides (fucoidan) and a radionuclide (technetium-99m) for the detection of P-selectin expression in cardiovascular diseases. After extraction and fractionation from brown seaweeds, the good manufacturing practice (GMP) production of a low molecular weight (LMW) fucoidan of 7 kDa was achieved and full physicochemical characterization was performed. The regulatory toxicology study in rats of the GMP batch of LMW fucoidan revealed no adMarine drugsPharmaceutical Development and Safety Evaluation of a GMP-Grade Fucoidan for Molecular Diagnosis of Cardiovascular Diseases.PMC6949921FP7-NMP-2012-LARGE-6-309820ANR-13-LAB1-0005-01Chauvierre CRolland LChaubet FBussi SZheng KHChollet LAid-Launais RChahid YLe Guludec DBonafe RRossi SStroes ESGFulop TSzebeni JDezsi LRouzet FMaire MCabella CAerts JLetourneur DfalsePharmaceutical Development and Safety Evaluation of a GMP-Grade Fucoidan for Molecular Diagnosis of Cardiovascular Diseases.The adhesion molecule P-selectin is present on the cell surface of both activated endothelium and activated platelets. The present study describes the pharmaceutical development, safety evaluation, and preclinical efficacy of a micro-dosed radiotracer. The macromolecular nanoscale assembly consisted of a natural compound made of a sulfated fucose-rich polysaccharides (fucoidan) and a radionuclide (technetium-99m) for the detection of P-selectin expression in cardiovascular diseases. After extraction and fractionation from brown seaweeds, the good manufacturing practice (GMP) production of a low molecular weight (LMW) fucoidan of 7 kDa was achieved and full physicochemical characterization was performed. The regulatory toxicology study in rats of the GMP batch of LMW fucoidan revealed no ad2019-01-01T00:00:00Z2019 Dec2025-04-04T11:07:00.546Z2020-05-22T08:00:08ZS-EPMC69499213184231910.3390/md17120699