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Radiosynthesis, Quality Control, and Small Animal Positron Emission Tomography Imaging of 68Ga-Labelled Nano Molecules
Published on: October 4, 2024
Pharmacovigilance in radiopharmaceuticals
Rishi Kumar1, Vivekanandan Kalaiselvan2, Rakesh Kumar1
1Pharmacovigilance Division, Indian Pharmacopoeia Commission, National Coordination Centre-Pharmacovigilance Programme of India, India.
The Indian Pharmacopoeia Commission ensures drug standards, including radiopharmaceuticals (RPs). This article introduces adverse drug reaction reporting for nuclear medicine professionals handling RPs, addressing potential patient reactions.
Area of Science:
- Pharmacology
- Nuclear Medicine
- Drug Safety
Background:
- The Indian Pharmacopoeia Commission (IPC) sets standards for drugs, including radiopharmaceuticals (RPs).
- RPs are utilized in India for diagnostic and therapeutic applications.
- Despite small doses, RPs can elicit adverse drug reactions (ADRs) in patients.
Purpose of the Study:
- To introduce the system of adverse drug reaction reporting.
- To educate the nuclear medicine community on ADR reporting for RPs.
Main Methods:
- This article is a review and introduction to an existing reporting system.
- No new experimental methods were employed.
Main Results:
- An ADR reporting system for RPs is available.
- The system aims to improve the safety profile of RPs.
Conclusions:
- Effective ADR reporting is crucial for radiopharmaceutical safety.
- Nuclear medicine practitioners should be aware of and utilize ADR reporting mechanisms.
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