Position paper on requirements for toxicological studies in the specific case of radiopharmaceuticals
نویسندگان
چکیده
This is a position paper of the Radiopharmacy Committee of the EANM (European Association of Nuclear Medicine) addressing toxicology studies for application of new diagnostic and therapeutic radiopharmaceuticals (RP) that are not approved (i.e., not having a marketing authorization or a monograph in the European Pharmacopoeia), excluding endogenous and ubiquitous substances in humans. This paper discusses the requirements for clinical trials with radiopharmaceuticals for clinical research applications, not necessarily intended to aim at a marketing authorization. If marketing authorization is intended, scientific advice of the competent authorities is mandatory and cannot be replaced by this position paper. The position paper reflects the view of the Radiopharmacy Committee of the EANM and can be used as a basis for discussions with the responsible authorities.
منابع مشابه
Structural requirements for auditing educational and research processes (Case: Shahed University)
The present study identified the structural requirements for auditing educational and research processes in universities. The problem posed in this research is the lack of specific and appropriate structural dimensions for educational and research auditing. The study is descriptive and used the exploratory method. Questionnaires were used to collect data. Data analysis revealed that formalizati...
متن کاملبررسی مقایسهای صحت تشخیصی 2 روش سیتولوژی و برش انجمادی حین عمل جراحی در بیمارستانهای تابعه دانشگاه علوم پزشکی ایران از تیرماه 1380 تا دی ماه 1381
Performing frozen section is a common intraoperative consult with the goal of determining the lesion as benign or malignant. Since frozen section needs specific technical requirements and costs a lot therefore, in some studies cytology is used as an alternative method. Most of these studies have been done on specific organs and a few of them on all organs of the body. Therefore, we ...
متن کاملToxicological Investigation of Acute Cyanide Poisoning of a 29-year-old Man: A Case Report
Background: Cyanide poisoning is frequently lethal, Because of the early onset of severe symptoms and difficulty in the diagnosis. Case: The case was a 29-year-old boy who collapsed suddenly after taking a bottle of beer in a bar. Samples, such as peripheral blood, stomach contents, bile fluid, urine and mouth swabs, were prepared using standard autopsy procedure and were subjected to analysis...
متن کاملRadiopharmaceutical regulation worldwide - The resemblances and the differences [Persian]
A Radiopharmaceutical is a radioactive compound used for the diagnosis and treatment of human diseases. Radiopharmaceuticals are among the most highly regulated materials administered to patients because they are controlled both as drugs and as radioactive substances. The use of radiopharmaceuticals for any purpose is governed by regulatory agencies in different countries all over the wor...
متن کاملThe current status and future of theranostic Copper-64 radiopharmaceuticals
Copper-64 was produced in large scales and high specific activities in late 1990s’ using compact cyclotrons based by 64Ni(p,n)64Cu reaction and many radiopharmaceuticals developed since then by various groups based on interesting physicochemical and nuclear properties of the radionuclide. The unique emission of beta particles as well as positron particles offers a spectacu...
متن کامل