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Dr David Cook

 

Transforming-a-paper-based-trial-master-file-to-a-streamlined-electronic-document-management-solution-at-Sanofi
Transforming-a-paper-based-trial-master-file-to-a-streamlined-electronic-document-management-solution-at-Sanofi
article

Ensuring patient safety during clinical trials; translation to preclinical drug discovery

Ensuring patient safety during clinical trials is of paramount consideration…

3 September 2012 | By David Cook & James Milligan, AstraZeneca

Ensuring patient safety during clinical trials is of paramount consideration with stringent monitoring built into trials (and beyond) and the design and interpretation of safety outcomes subject to a large amount of regulation. As a result, it is rare for clinical trials to produce extreme adverse drug reactions but it…

Figure 1 Overview of DILI-sim A. Schematic overview of the key biological processes represented in DILI-sim B. Overview of different modules within DILI-sim. Each module is itself a model that captures a specific area of relevant biology, pharmacology and metabolism. This modular approach to DILI-sim allows the overall model to be built in manageable, testable pieces C. Knowledge management aspects of DILI-sim. Under each of the models, the supporting evidence is explicitly captured and hence the model acts as a highly structured knowledge repository
Figure 1 Overview of DILI-sim A. Schematic overview of the key biological processes represented in DILI-sim B. Overview of different modules within DILI-sim. Each module is itself a model that captures a specific area of relevant biology, pharmacology and metabolism. This modular approach to DILI-sim allows the overall model to be built in manageable, testable pieces C. Knowledge management aspects of DILI-sim. Under each of the models, the supporting evidence is explicitly captured and hence the model acts as a highly structured knowledge repository
article

Applying systems biology and computer simulations to predicting idiosyncratic DILI

Idiosyncratic drug-induced liver injury (DILI) is a rare adverse drug…

19 August 2010 | By David Cook, Associate Director, Global Safety Assessment, AstraZeneca

Idiosyncratic drug-induced liver injury (DILI) is a rare adverse drug reaction which accounts for a significant amount of patient suffering, including death. Currently, idiosyncratic DILI is unpredictable and as a result arises late in the drug development process or even post-marketing. The prediction of idiosyncratic DILI based on preclinical or…