Starting or Strengthening a Drug Bulletin - A Practical Manual
(2005; 165 pages) View the PDF document
Table of Contents
View the documentPreface
View the documentHow the manual was produced
View the documentAbout ISDB
View the documentExecutive summary
Open this folder and view contents1. Introduction
Open this folder and view contents2. Rational use of medicines
Open this folder and view contents3. What are drug bulletins?
Open this folder and view contents4. Defining aims, target and type of bulletin
Open this folder and view contents5. Planning resources
Open this folder and view contents6. Planning bulletin production: schedules and timing
Open this folder and view contents7. The editorial process
Open this folder and view contents8. Reviewing a new drug: is it a therapeutic advance?
Close this folderAnnexe to Chapter 8: Evaluating harm
View the document8.An-1 Talk about harm, not risk
View the document8.An-2 Assessment of causation of a harmful effect
Close this folder8.An-3 Assessing coherence with preclinical data
View the document8.An-3.1 General principles
View the document8.An-3.2 Chemical structure of new drugs
View the document8.An-3.3 Considering the profile of adverse effects
View the document8.An-3.4 Ratio of toxic and efficacy level in the same animal
View the document8.An-3.5 Extrapolation of animal toxicity (safety) level to humans
View the document8.An-4 References
Open this folder and view contents9. Design and production
Open this folder and view contents10. Dissemination
Open this folder and view contents11. Organizational and legal issues
Open this folder and view contents12. Evaluating quality and usefulness
Open this folder and view contents13. Partnership and collaboration
Open this folder and view contents14. Keeping records and creating a memory
Open this folder and view contentsAppendix: Electronic sources of information
 

8.An-3.1 General principles

If you want to assess whether or not any adverse events observed in the clinical trials and/or in practice are related to the treatment, not only other clinical data but also preclinical data can help greatly with assessing causality of the events.

It is important to discuss the coherence (congruence) with other evidence, especially from laboratory experiments: i.e. pharmacological tests and toxicity tests. Search for similar findings as observed in humans in the safety pharmacological tests and in the acute to chronic toxicity tests. If you find any, compare the area under the curve (AUC) values for active ingredient (preferably the unbound drug) between the animal and human. If they are close, it suggests that the adverse event observed in humans is associated with the drug. Be aware that pharmaceutical companies generally do not want to disclose critically important data for assessing risks. So ask for those important data whenever you can and search the web sites of regulatory agencies such as that of the FDA.

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