Bio-Nucleonics
Encyclopedia
Bio-Nucleonics Inc. is a privately-held, life sciences
company located in the United States. The company develops, manufactures, and markets radiopharmaceuticals
, medical devices, and imaging agents to detect and treat cardiovascular
, oncological
, and neurological diseases. Approved by the U.S Food and Drug Administration
(FDA), the U.S. Nuclear Regulatory Commission, and the Florida Board of Pharmacy, it is the only U.S. company focused on the development and production of generic radiopharmaceuticals.
, Good Laboratory Practice
, and Quality System Requirements
.
, which is the generic version of Metastron. Generic Strontium-89 is an option to consider for cancer bone pain
therapy. It imitates the behavior of calcium and is preferentially absorbed by bone, concentrating at sites of painful metastatic bone disease. Generic Strontium-89 injection is a pure beta emitter
, and selectively irradiates sites of primary and metastatic bone involvement with minimal irradiation
of soft tissues distant from bone lesions.
Life sciences
The life sciences comprise the fields of science that involve the scientific study of living organisms, like plants, animals, and human beings. While biology remains the centerpiece of the life sciences, technological advances in molecular biology and biotechnology have led to a burgeoning of...
company located in the United States. The company develops, manufactures, and markets radiopharmaceuticals
Radiopharmacology
Radiopharmacology is the study and preparation of radiopharmaceuticals, which are radioactive pharmaceuticals. Radiopharmaceuticals are used in the field of nuclear medicine as tracers in the diagnosis and treatment of many diseases. Many radiopharmaceuticals use technetium-99m which has many...
, medical devices, and imaging agents to detect and treat cardiovascular
Cardiovascular disease
Heart disease or cardiovascular disease are the class of diseases that involve the heart or blood vessels . While the term technically refers to any disease that affects the cardiovascular system , it is usually used to refer to those related to atherosclerosis...
, oncological
Oncology
Oncology is a branch of medicine that deals with cancer...
, and neurological diseases. Approved by the U.S Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA), the U.S. Nuclear Regulatory Commission, and the Florida Board of Pharmacy, it is the only U.S. company focused on the development and production of generic radiopharmaceuticals.
Regulations
The company is regulated by the U.S. Food and Drug Administration (FDA), the U.S. Nuclear Regulatory Commission, the Florida Bureau of Radiation Control, and the Florida Board of Pharmacy. Its products undergo rigorous validation and testing in accordance with current Good Manufacturing PracticeGood Manufacturing Practice
"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods,...
, Good Laboratory Practice
Good Laboratory Practice
In the experimental research arena, the phrase good laboratory practice or GLP specifically refers to a quality system of management controls for research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical ...
, and Quality System Requirements
Quality management system
A quality management system can be expressed as the organizational structure, procedures, processes and resources needed to implement quality management.-Elements of a Quality Management System:# Organizational structure# Responsibilities# Methods...
.
Products and services
Bio-Nucleonics' lead product is Generic Strontium Sr-89 Injection USP (Strontium-89)Strontium-89
Strontium-89 is an isotope of strontium.It is treated by the body in a similar manner to calcium, and is preferentially deposited metabolically active regions of the bone.It is an artificial radioisotope which is used in treatment of bone cancer...
, which is the generic version of Metastron. Generic Strontium-89 is an option to consider for cancer bone pain
Bone pain
Bone pain is a debilitating form of pain emanating from the bone tissue. It occurs as a result of a wide range of diseases and/or physical conditions and may severely impair the quality of life for patients who suffer from it...
therapy. It imitates the behavior of calcium and is preferentially absorbed by bone, concentrating at sites of painful metastatic bone disease. Generic Strontium-89 injection is a pure beta emitter
Common beta emitters
-Strontium:Strontium-90 is a commonly used beta emitter used in industrial sources. It is also been used as a thermal power source in radioisotope thermoelectric generator power packs. These use heat produced by radioactive decay of strontium-90 to generate heat, which can be converted to...
, and selectively irradiates sites of primary and metastatic bone involvement with minimal irradiation
Irradiation
Irradiation is the process by which an object is exposed to radiation. The exposure can originate from various sources, including natural sources. Most frequently the term refers to ionizing radiation, and to a level of radiation that will serve a specific purpose, rather than radiation exposure to...
of soft tissues distant from bone lesions.