Application of response surface methodology and quality by design to [68Ga]Ga-PSMA-11 preparation

Application of response surface methodology and quality by design to [68Ga]Ga-PSMA-11 preparation

In this study, the optimum conditions for the synthesis of [ 68 Ga]Ga-PSMA-11 were determined for the first time using the Quality by Design (QbD). The response surface methodology was used to estimate the effect of input variables (PSMA-11 concentration, time, reaction temperature, and pH) on the r...

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Veröffentlicht in:Journal of radioanalytical and nuclear chemistry 2024, Vol.333 (1), p.43-51
Hauptverfasser: Pehlivanoglu, Huseyin, Ocak, Meltem, Caglar-Andac, Sena
Format: Artikel
Sprache:eng
Schlagworte:
Chemistry
Chemistry and Materials Science
Diagnostic Radiology
Hadrons
Heavy Ions
Inorganic Chemistry
Nuclear Chemistry
Nuclear Physics
Physical Chemistry
Radiochemistry
Response surface methodology
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Zusammenfassung:In this study, the optimum conditions for the synthesis of [ 68 Ga]Ga-PSMA-11 were determined for the first time using the Quality by Design (QbD). The response surface methodology was used to estimate the effect of input variables (PSMA-11 concentration, time, reaction temperature, and pH) on the responses calculated as the percentage of the radiochemical purity and the RR configuration. Since using QbD principles in the production of radiopharmaceuticals is not common, this study will help increase the number of applications in this field and ensure quality in radiopharmaceutical manufacturing, allowing decreased cost and the number of experiments. Graphical abstract
ISSN:0236-5731
1588-2780
DOI:10.1007/s10967-023-09246-z