Contrast Media: Safety Issues and ESUR Guidelines by Henrik S. Thomsen, Judith A. W. Webb

By Henrik S. Thomsen, Judith A. W. Webb

This is the 3rd version of a really profitable booklet that initially emerged from the paintings of a committee manage by means of the eu Society of Urogenital Radiology in 1994 to contemplate the protection of distinction media used for diagnostic imaging. the recent version not just totally updates the former variation, but additionally comprises new chapters on advanced issues corresponding to pediatric matters and functional facets of off-label distinction media use. complete attention is given to the various assorted issues of safety on the subject of iodine-based distinction media, gadolinium-based distinction media, microbubbles for ultrasound, and barium sulfate. The textual content contains chapters on either acute and behind schedule non-renal adversarial reactions and on renal hostile reactions. all the questions usually raised in radiological perform are addressed. This publication, awarded in a convenient, easy-to-use layout, offers a useful, detailed, and exceptional resource of information.

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The aim is to show similar technical and diagnostic performances (sensitivity and specificity) as well as similar or better safety profile for the same patient population or indication. This relatively limited evidence for assessing the clinical benefit of these products is based on the claim(s) for the same indication which has already been granted to the similar approved contrast agent (the comparator). If the aim is to show superiority of the new contrast agent, this limited evidence may not be sufficient and, in addition to better technical and diagnostic performance, the impact on diagnostic thinking and patient management (see below) may need to be shown Quality Aspects Chemical, pharmaceutical, and biological aspects of the contrast agent should be presented in detail in the application.

1 Good Clinical Practice (GCP) and Ethics The clinical trials used to support the marketing authorization application should be designed, conducted, recorded, and reported in compliance with the GCP principles as laid down in regulations and guidelines. In addition, all studies should be conducted in accordance with the Declaration of Helsinki. 2 Fundamental Requirements According to the guideline on clinical evaluation of diagnostic agents (EMEA 2010), in order to establish an indication for a contrast agent, it is necessary to demonstrate its benefit by assessing its technical performance (including 35 procedural convenience), diagnostic performance, impact on diagnostic thinking, impact on patient management, impact on clinical outcome and safety.

Indian J Pediatr 75:1133–1136 Jansen RM, Gouws C (2009) Clinical, legal and ethical implications of the intra-ocular (off-label) use of bevacizumab (avastin)–a South African perspective. S Afr Med J 99:446–449 Kairuz TE, Gargiulo D, Bunt C et al (2007) Quality, safety and efficacy in the ‘off-label’ use of medicines. Curr Drug Saf 2:89–95 Knoester PD, Belitser SV, Deckers CL et al (2004) Diffusion of the new antiepileptic drug lamotrigine in Dutch clinical practice. Eur J Clin Pharmacol 60:751–758 Knopp MV, Lodemann M, Kage U et al (2001) Administration of MR contrast agents outside of approved indications (off-label use).

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