According to MHRA, an estimated risk of MI of 0.9 was shown in an analysis of clinical trials. It has concluded that no firm conclusions can be drawn on the association between abacavir and MI.doi:10.2165/00128415-200912610-00004NoneSpringer International PublishingReactions Weekly...
Regulating clinical trials of medicines and medical devices Monitoring and ensuring compliance with statutory obligations relating to medicines and medical devices through inspection, taking enforcement action where necessary Promoting good practice in the safe use of medicines and medical devices Managing the...
The report summarises the results of a review requested by the EMA's Pharmacovigilance Working Party and the MHRA which found that 6%-12% of adult and paediatric patients in clinical trials of atomoxetine experienced clinically important increases in heart rate and/or BP, and that these increases...
In two global clinical trials of CASGEVY in SCD and TDT, the trials met their respective primary outcome of becoming free from severe VOCs or transfusion independent for at least 12 consecutive months. Once achieved, these benefits are potentially expected to be life-long. The sa...
MedicinesforHumanUse(ClinicalTrials)Regulations2004(SI:1031) “Eachindividualinvolvedinconductingatrialshallbequalifiedbyeducation,training,andexperiencetoperformhisorherrespectivetask(s)” QualificationsandTraining: DelegationLog TrainingRecord DelegationofDuties: ...
from its facilities in Europe and the USA. The company has proven expertise in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical trials and in-market production. The company's wide range of...