IAEA/WHO GUIDELINE ON GOOD MANUFACTURING PRACTICES FOR INVESTIGATIONAL RADIOPHARMACEUTICAL PRODUCTS.
Background In view of a rapidly expanding field of molecular imaging and targeted radiopharmaceutical therapy, combined with the absence of a dedicated guidance specific to the manufacture of investigational radiopharmaceuticals used in both early and late clinical trials, the World Health Organizat...
| Publicado en: | WHO Drug Information Vol. 35; no. 3; pp. 612 - 637 |
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| Formato: | glossary Journal Article |
| Publicado: |
World Health Organization
2021
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| Acceso en línea: | Ver este registro en EBSCOhost |
| Sumario: | Background In view of a rapidly expanding field of molecular imaging and targeted radiopharmaceutical therapy, combined with the absence of a dedicated guidance specific to the manufacture of investigational radiopharmaceuticals used in both early and late clinical trials, the World Health Organization (WHO), in partnership with the International Atomic Energy Agency (IAEA), has raised the urgency for the generation of a new IAEA/WHO guideline on good manufacturing practices for investigational radiopharmaceutical products . The objective of this guideline is to meet current expectations and trends in good manufacturing practices (GMP) specific to investigational radiopharmaceuticals used in clinical trials (i.e. Phase I, Phase II and Phase III trials) and to harmonize the text with the principles from other related international guidelines. This text was developed in alignment with the Good manufacturing practices; supplementary guidelines for the manufacture of investigational pharmaceutical products for clinical trials in humans (1). |
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