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Radiopharmaceutical Clinical trial designs on discussion in Cuba

Havana, Oct 29 (Prensa Latina) Clinical trial designs and preclinical studies of radiopharmaceuticals are among the issues to discuss on Tuesday, at the Regional Workshop on Health Regulatory Requirements for these products.

The workshop’s second day at the Palco Hotel in this capital, which runs until October 31, will present the national regulatory frameworks for these drugs in countries such as Argentina, Bolivia, Costa Rica, Colombia, Brazil, Cuba, and Mexico.

Representatives from the Dominican Republic, Panama, Peru, and Uruguay will also put in view, the essential points and major difficulties in regulating radiopharmaceuticals, which the International Atomic Energy Agency (IAEA) defined as medicines containing, among other things, radioactive forms of chemical elements, known as radioisotopes.

Depending on the radiation they produce, these radioisotopes can diagnose or treat several health problems, ranging from imaging many different organs, such as the brain, heart, kidneys, and bones, to treating cancer and hyperthyroidism.

During the opening ceremony, Mayka Guerrero, head of the Specialized Center for Diagnosis and Therapy of the Cuban Center for Surgical Medical Research (CIMEQ), pointed out that one of the workshop’s objectives was to “share experiences in complying with health regulatory requirements during the radiopharmaceutical approval process, besides learning about success cases and requirements in clinical trials.”

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