Production, Quality Control and Clinical Applications of Radiosynovectomy Agents

Therapeutic radiopharmaceuticals play a significant role in nuclear medicine, particularly in radiation synovectomy (RSV). However, the lack of generic and peer-reviewed production, quality control, clinical application guidelines, and recommendations is a concern. This publication provides recommendations and suggestions for production, quality control, and quality assurance procedures for Member State laboratories, with a focus on the latest RSV agents. It also proposes standard operating procedures for RSV application in patients to establish comparable levels of control.

Format: Paperback / softback
Length: 123 pages
Publication date: 30 August 2021
Publisher: IAEA

Therapeutic radiopharmaceuticals hold a pivotal position in modern nuclear medicine, exerting a positive influence on disease diagnosis and treatment. One notable application is radiation synovectomy (RSV), where the use of radiopharmaceutical agents has gained significant attention. In the past, RSV agents were commonly composed of simple colloids. However, in recent years, there has been a shift towards the development of matrixes labeled with short/medium range beta emitters. Nonetheless, concerns arise regarding the lack of generic and peer-reviewed production, quality control, clinical application guidelines, and recommendations for these agents. This publication aims to address these concerns by presenting recommendations and suggestions for production, quality control, and quality assurance procedures for Member State laboratories responsible for radiopharmaceutical production, particularly focusing on the latest RSV agents. Additionally, it proposes standardized operating procedures for RSV application in patients. The primary objective of this publication is to provide guidance to both newcomers and established professionals in the field, enabling them to establish comparable levels of control and ensure the safe and effective use of radiopharmaceuticals in RSV therapy.
Therapeutic radiopharmaceuticals play a major role in today's nuclear medicine with a positive impact on the diagnosis and treatment of diseases. One area of application is radiation synovectomy (RSV). Previously,RSV agents were often simple colloids. More recently,matrixes labelled with short/medium range beta emitters have been developed. However,the lack of generic and peer?reviewed production,quality control as well as clinical application guidelines and recommendations,are a major concern for their application in patients. This publication presents recommendations and suggestions for production,quality control and quality assurance procedures for Member State laboratories in charge of radiopharmaceutical production,with a focus on the latest RSV agents. It also proposes standard operating procedures for RSV application in patients. The publication aims to assist both newcomers and those currently working in the field in establishing comparable levels of control.

The use of therapeutic radiopharmaceuticals in nuclear medicine has significantly contributed to the diagnosis and treatment of various diseases. Radiation synovectomy (RSV) is one such application where radiopharmaceutical agents play a vital role. Traditionally, RSV agents were commonly composed of simple colloids. However, in recent years, there has been a shift towards the development of matrixes labeled with short/medium range beta emitters. This shift has brought about several advantages, including improved targeting and increased efficacy.

Despite these advancements, concerns have arisen regarding the lack of generic and peer-reviewed production, quality control, clinical application guidelines, and recommendations for these agents. This publication aims to address these concerns by presenting recommendations and suggestions for production, quality control, and quality assurance procedures for Member State laboratories.

Production:

Member State laboratories responsible for radiopharmaceutical production should adhere to established guidelines and regulations to ensure the safety and efficacy of radiopharmaceuticals. These guidelines include Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Distribution Practices (GDP). Member State laboratories should establish robust quality control systems to monitor the production process and ensure the quality of radiopharmaceuticals. This includes the use of validated analytical methods, quality control samples, and appropriate quality control measures.

Quality control:

Quality control is an essential aspect of radiopharmaceutical production. Member State laboratories should establish robust quality control systems to monitor the quality of radiopharmaceuticals throughout the production process. This includes the use of validated analytical methods, quality control samples, and appropriate quality control measures. Quality control measures should include batch release testing, stability testing, and potency testing.

Quality assurance:

Quality assurance is a critical component of radiopharmaceutical production. Member State laboratories should establish a quality assurance program to ensure the quality of radiopharmaceuticals. This program should include regular quality audits, training programs, and quality control measures. Quality assurance measures should include the use of validated analytical methods, quality control samples, and appropriate quality control measures.

Clinical application guidelines and recommendations:

Clinical application guidelines and recommendations are essential for the safe and effective use of radiopharmaceuticals. Member State laboratories should develop clinical application guidelines and recommendations for RSV agents. These guidelines should include information on the appropriate dosage, administration route, and duration of treatment. They should also include information on potential side clinical side effects and contraindications.

Standard operating procedures:

Standard operating procedures (SOPs) are essential for the safe and effective use of radiopharmaceuticals. Member State laboratories should develop SOPs for RSV agents. These SOPs should include information on the appropriate equipment, personnel, and environmental conditions. They should also include information on the preparation and administration of radiopharmaceuticals.

Conclusion:

The use of therapeutic radiopharmaceuticals in nuclear medicine has significantly contributed to the diagnosis and treatment of various diseases. Radiation synovectomy is one such application where radiopharmaceutical agents play a vital role. The lack of generic and peer-reviewed production, quality control, clinical application guidelines, and recommendations for these agents is a major concern. This publication presents recommendations and suggestions for production, quality control, and quality assurance procedures for Member State laboratories. It also proposes standard operating procedures for RSV application in patients. The primary objective of this publication is to provide guidance to both newcomers and established professionals in the field, enabling them to establish comparable levels of control and ensure the safe and effective use of radiopharmaceuticals in RSV therapy.

Weight: 289g
ISBN-13: 9789201185204