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Advances in Radiotherapy
& Nuclear Medicine QC parameters in radiopharmaceuticals

1. Introduction treatment of bone cancer are frequently used therapeutic
radiopharmaceuticals.
The World Health Organization (WHO) defines
radiopharmaceuticals as novel radioisotope-infused 2.2. Diagnostic radiopharmaceuticals
pharmaceutical preparations that are employed in Diagnostic radiopharmaceuticals are tracers used to track
critical clinical settings for therapy or diagnosis.
Radiopharmaceutical preparations contain radioactive human disease progression. These tracers have a short-
elements (radioisotopes and radioisotope-labeled lived isotope that is often bound to a ligand or carrier.
compounds) designed for diagnosis and therapy. For example, technetium-99m dimercaptosuccinic acid
1
Radiopharmaceuticals labeled with positron emission is used for the management of medullary thyroid cancer,
99m
tomography and single-photon emission computed and technetium-99m medronate ( Tc-methylene
4
tomography radionuclides are highly effective in diagnosing diphosphonate) is frequently utilized for bone scintigraphy.
malignancies, neurological and neurodegenerative illnesses, 2.3. Theranostic radiopharmaceuticals
inflammation, and bacterial infections. Based on the
2
standards established by the International Pharmacopoeia Theranostic radiopharmaceuticals combine the diagnostic
of the WHO, radiopharmaceutical medications can be qualities of a radionuclide with the curative potential of
categorized into the following four groups: virtually identical therapeutic analog radionuclides to
i. Radiopharmaceutical preparation: This medicinal give the selected patient the benefit of both imaging and
product is ready to use and contains a radionuclide a customized and targeted treatment. Examples include
68
necessary for its medical purpose. It might be suitable 68 Ga DOTATATE/ Ga prostate-specific membrane
for a few different diagnostic or therapeutic uses antigen (PSMA)-11 to evaluate tumor progression,
ii. Radionuclide generator: This comprises a system therapy planning, and monitoring of treatment response
that separates a radionuclide with a short half-life of neuroendocrine tumors and metastatic prostate cancer;
177
(daughter radionuclide) from one with a long half- and 177 Lu DOTATATE/ Lu PSMA-617 used to manage
life (parent radionuclide), and then uses the separated and treat somatostatin receptor-positive neuroendocrine
radionuclides to create a radiopharmaceutical tumor of the gastroenteropancreatic region and PSMA-
preparation expressing metastatic castration-resistant prostate cancer. 5
iii. Radiopharmaceutical precursor: It is a radionuclide
for radiolabeling, creating a radiopharmaceutical 3. Role of pharmacopoeia and status of
preparation radiopharmaceutical monographs
iv. Kit for radiopharmaceutical preparations: It contains Pharmacopoeia is established to avoid marketing
the stabilized pharmaceutical component of the inconsistent medications while ensuring drug quality,
radiopharmaceutical preparation and excipients safety, and efficacy. Many countries possess national
without the radionuclides. Before using it for pharmacopeias of their own, such as the British
medicinal purposes, it is to be reconstituted with a Pharmacopoeia (BP) for the UK and the US Pharmacopoeia
specific radionuclide. It is usually a multidose vial, (USP) for the US of America. The WHO also produces
and additional procedures may be necessary for its a pharmacopoeia, International Pharmacopoeia, for
creation (boiling, heating, filtration, and buffering). regular use by its member countries. Likewise, in India,
6
They are usually made to be used within 12 h of Indian Pharmacopoeia (IP) is acknowledged as the
preparation. 3
official standard-setting document for drugs produced
2. Application-based classification of and/or marketed in India. On behalf of the Ministry of
radiopharmaceuticals Health and Family Welfare, Government of India, IP is
published periodically by the IP Commission following the
2.1. Therapeutic radiopharmaceuticals requirements of the Drugs and Cosmetics Act, 1940, and
Rules 1945 thereunder. IP consists of several authoritative
Therapeutic radiopharmaceuticals are molecules with
radioactive labels that target a specific organ and localize methods for analyzing pharmaceuticals and defining their
identity, purity, and potency.
7
at the site to give a therapeutic dosage of ionizing radiation
for destroying dysfunctional cells. This is referred to as To oversee the quality of radiopharmaceutical
radionuclide therapy. For instance, 131 I sodium iodide preparations, the IP Commission, for the first time, includes
for the treatment of metastatic thyroid cancer, 32 P 19 radiopharmaceutical monographs along with one general
phosphate for the treatment of blood conditions and chapter in IP 2014. For radiopharmaceutical preparations, IP
intracavitary malignancies, and 89 Sr chloride for the 2022 currently lists 37 monographs, 30 of which are employed

Volume 2 Issue 3 (2024) 2 doi: 10.36922/arnm.3619