In this study, the preparation of 111In-Bleomycin complex was optimized for temperature, time, concentration and pH during several experiments. The results showed that by the addition of bleomycin to 111In-InCl3 sample (dried under flow of N2) and heating the mixture up to 90-100°C the RADIOPHARMACEUTICAL can be obtained in 99.5% yield and a specific activity of 1.745 Ci/mmol. The final sample was injected into fibro sarcoma-bearing mice via their tail vein. Satisfactory preliminary SPECT images were acquired between 2-4 hours post-injection showing suitable accumulation in fibro sarcoma tumors

A RADIOPHARMACEUTICAL is a radioactive compound used for the diagnosis and treatment of human diseases. RADIOPHARMACEUTICALs are among the most highly regulated materials administered to patients because they are controlled both as drugs and as radioactive substances.The use of RADIOPHARMACEUTICALs for any purpose is governed by regulatory agencies in different countries all over the world. Application of RADIOPHARMACEUTICALs in humans was almost unregulated Until the late I 950s. Since then a progression of regulations have been imposed on the use of these compounds in humans. The United states, United Kingdom, European community, Australia and New Zealand are among the pioneer countries in legislation of regulations concerning the preparation, distribution and use of radio pharmaceuticals. Several regulations, guidelines and reports have been published by federal or professional agencies involved in nuclear pharmacy and nuclear medicine to improve the quality of RADIOPHARMACEUTICAL services. While there are similarities in the backbone of the regulations and guidelines regarding RADIOPHARMACEUTICAL practice worldwide, the Comprehensiveness of these regulations varies considerably from country to country and even among states of a country.In order to establish a set of RADIOPHARMACEUTICAL regulations for Iran, reviewing the previously published regulations and guidelines and access their conformity to domestic situations have valuable position and selected acts and topics based on local exigencies may serve as a guide for legislation of the regulations for importation, production and use of RADIOPHARMACEUTICALs in Iran.The aim of this review is to summarize some of the important aspect of RADIOPHARMACEUTICAL regulations and principal agencies that have regulatory authority over the practice of radio pharmacy.

Concentration of kryptofix 2.2.2 in [18F] FDG solutions and standard solutions of kryptofix 2.2.2 was determined by two methods: Visualization of combination of K2.2.2 with iodine vapor and iodoplatinate reagent. In both methods, concentration difference of K2.2.2 solutions was appeared as difference in color intensity of revealed spots on TLC. The detection limit of K2.2.2 by iodine vapor and iodoplatinate reagent is 25 and 2 ppm, respectively. Both methods can be used to release or reject the quality of [18F] FDG RADIOPHARMACEUTICAL for intravenous injection, but the second method is more suitable because of taking shorter time.

There is significant interest and value in utilizing Digital Twins (DTs) to extend healthcare from ‘, one-size-fits-all’,to personalized therapies. RADIOPHARMACEUTICAL Therapies (RPTs), which represent very powerful developments in the battle against cancer, are no exceptions to this. In fact, Theranostic Digital Twins (TDTs), which we elaborate in this work, present viable and feasible approaches to personalize RPTs. TDTs are computational representations of the human body that, unlike images, are operable,i. e. virtual trials can be conducted on them to propose optimal therapies for individual patients. TDTs can be built using Physiologically Based Pharmacokinetic (PBPK) models. This work elaborates that TDTs can be developed in static, dynamic and interactive modes towards routine use in future clinical settings. TDTs will open a new area of theranostics research and development in terms of new RADIOPHARMACEUTICAL designs, synthesis and enabling of more optimal therapies.

Introduction: Previously, 186Re and 188Re radioisotopes have been produced through appropriate activities, and each of them has been used for therapeutic applications. The 186Re and 188Re have unique properties, which make them proper for the treatment of tumors in different sizes. The long-range 188Re, is suitable for the annihilation of large tumors. In contrast, the short-range 186Re is desirable for the destruction of small tumors. The aim of this study was to find the suitable time for rhenium irradiation in order to simultaneously produce radionuclides with both appropriate and identical activities. Material and Methods: To reach 186Re and 188Re with appropriate activities to produce compositional RADIOPHARMACEUTICAL, we have investigated natural rhenium irradiation at different times to produce 186Re and 188Re simultaneously with appropriate and identical activities to reach compositional RADIOPHARMACEUTICAL. In this regard, the simultaneous production of 186Re and 188Re with appropriate activities were investigated analytically through natural rhenium irradiation in a reactor. The irradiation was assessed at different time intervals in order to reach appropriate activities for compositional RADIOPHARMACEUTICALs. Results: On the basis of the findings, 186Re and 188Re could be produced simultaneously with suitable and almost equal activities with irradiating natural rhenium for 4 days and considering 1 day for cooling. Moreover, the obtained results of this study revealed that the generated impurities were negligible. Conclusion: The optimization of natural rhenium irradiation time can help the simultaneous production of 186Re and 188Re with appropriate activities for compositional RADIOPHARMACEUTICALs.

Objective(s): Peptide Receptor Radionuclide Therapy (PRRT) with yttrium-90 (90Y) and lutetium-177 (177Lu)-labelled SST analogues are now therapy option for patients who have failed to respond to conventional medical therapy. In-house production with automated PRRT synthesis systems have clear advantages over manual methods resulting in increasing use in hospital-based radio pharmacies. We report on our one year experience with an automated RADIOPHARMACEUTICAL synthesis system.Methods: All syntheses were carried out using the Eckert & Ziegler Eurotope’s Modular-Lab Pharm Tracer® automated synthesis system. All materials and methods used were followed as instructed by the manufacturer of the system (Eckert & Ziegler Eurotope, Berlin, Germany). Sterile, GMP-certified, no-carrier added (NCA) 177Lu was used with GMPcertified peptide. An audit trail was also produced and saved by the system. The quality of the final product was assessed after each synthesis by ITLCSG and HPLC methods.Results: A total of 17 [177Lu]-DOTATATE syntheses were performed between August 2013 and December 2014. The amount of radioactive [177Lu]- DOTATATE produced by each synthesis varied between 10-40 GBq and was dependant on the number of patients being treated on a given day. Thirteen individuals received a total of 37 individual treatment administrations in this period. There were no issues and failures with the system or the synthesis cassettes. The average radiochemical purity as determined by ITLC was above 99% (99.8±0.05%) and the average radiochemical purity as determined by HPLC technique was above 97% (97.3±1.5%) for this period.Conclusions: The automated synthesis of [177Lu]-DOTATATE using Eckert & Ziegler Eurotope’s Modular-Lab Pharm Tracer® system is a robust, convenient and high yield approach to the radiolabelling of DOTATATE peptide benefiting from the use of NCA 177Lu and almost negligible radiation exposure of the operators.

Introduction: Bone metastases are a frequent complication of cancer that frequently causes intense pain. Pain palliation of these cancers is one of important goals in nuclear medicine. Therapeutic RADIOPHARMACEUTICALs are widely used to palliate pain of bone metastases. Among some RADIOPHARMACEUTICALs which are useful for radiotherapy, holmium-166 ethylenediamine-tetramethylenephosphonicacid (166Ho-EDTMP) is of particular interest for larger tumors.166Ho is a beta and gamma emitter with a high beta energy and appropriate halflife and gamma ray (81 keV) for imaging studies.Methods: 166Ho was prepared by neutron activation of natural 165Ho sample (purity >99/8%) and complex was obtained in room temperature by adding EDTMP ligand. In this research radiochemical purity was checked by paper chromatography and radionuclidic purity by recording the gamma ray spectra using a gamma spectrometer with an HPGe detector. The biodistribution studies of RADIOPHARMACEUTICAL, then was performed using wild type rats. In addition, the image was taken at 4 hours after administration of the RADIOPHARMACEUTICAL by a dual-head SPECT system.Results: 166Ho-EDTMP was prepared in excellent purity (above 99% in 30 minutes) and with high in-vitro stability. The major deposition of RADIOPHARMACEUTICAL (>70%) was found in bone, while RADIOPHARMACEUTICAL did not practically accumulate in other organs.Conclusion: 166Ho-EDTMP is a promising agent for bone pain palliation therapy in skeletal metastases in human with low undesired dose to other organs in rodents.