Barbara Wilkinson Brito, Tania Crombet, Carmen E. Viada

Analysis of adverse events of LC in clinical trial patients

Haematological and haemochemical adverse events

• Broschiertes Buch

Produktbeschreibung

The high incidence of cancer and the resulting death toll has led pharmaceutical companies to search for new products. During the clinical phase, an essential tool for studying the safety of a product is the knowledge and analysis of AEs. During monitoring and audits, among other problems, AEs of haematological and haemochemical origin were the least identified. In the review of some biotech product reports, it was found that only 8 AEs had been identified and documented, which suggested a more in-depth analysis of the LC data in order to identify and classify AEs and to demonstrate whether or not there was underreporting. In this study, 5 DBs were used, from which tables of laboratory values outside the normal range were formed, and these values were classified according to intensity. Of the 5 DBs, 582 AEs were obtained, 574 new AEs were found in this study. These results indicate that during the stages through which an AE passes to be detected, there is non-compliance with the GCP, which causes under-reporting in the safety data of a product.

Produktdetails

• Verlag: Our Knowledge Publishing
• Seitenzahl: 80
• Erscheinungstermin: 30. März 2023
• Englisch
• Abmessung: 220mm x 150mm x 6mm
• Gewicht: 137g
• ISBN-13: 9786205852187
• ISBN-10: 6205852187
• Artikelnr.: 67701472

Autorenporträt

B.Sc. in Pharmaceutical Sciences, 2000. MsC in Clinical Laboratory Sciences, 2007, IFAL, UH. 1st Level Technologist, 2009. Clinical Research Monitor and Responsible for EAS management at the Centre for Molecular Immunology. Author and co-author of more than 10 publications and papers presented at national and international scientific events.