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

Pehlivanoglu H., Ocak M., ÇAĞLAR ANDAÇ S.

JOURNAL OF RADIOANALYTICAL AND NUCLEAR CHEMISTRY, cilt.333, sa.1, ss.43-51, 2024 (SCI-Expanded) identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 333 Sayı: 1
  • Basım Tarihi: 2024
  • Doi Numarası: 10.1007/s10967-023-09246-z
  • Dergi Adı: JOURNAL OF RADIOANALYTICAL AND NUCLEAR CHEMISTRY
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, Aerospace Database, Analytical Abstracts, Biotechnology Research Abstracts, CAB Abstracts, Chemical Abstracts Core, Chimica, Communication Abstracts, Food Science & Technology Abstracts, INSPEC, Metadex, Pollution Abstracts, Public Affairs Index, Veterinary Science Database, Civil Engineering Abstracts
  • Sayfa Sayıları: ss.43-51
  • Anahtar Kelimeler: Quality by design, Radiopharmaceuticals, Response surface methodology, [68Ga]Ga-PSMA-11
  • İstanbul Üniversitesi Adresli: Evet

Özet

In this study, the optimum conditions for the synthesis of [Ga-68]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.