Publisher's Synopsis
This text examines the methods needed to analyze new adverse drug reactions, both inside and outside pharmaceutical companies. It evaluates the drug information cycle within pharmaceutical companies, which incorporates feedback about the drug from clinical trials (pre-marketing), epidemiological studies (pre- and post-marketing), and adverse event feedback (from doctors and drug information centres), an ongoing process known as "Pharmacovigilance". The information is then analyzed and collated prior to feeding the results back into the medical community and the drug development cycle. The book assesses existing methods of collection, storage and processing of adverse event data, and outlines ways of improving the drug information cycle. The fourth edition contains new chapters on: legal aspects; statistical methods; pharmacoepidemiology; quality of life; pharmacovigilance centres; mechanisms of ADRs; interactions and pharmacogenetics; and causality and signal recognition.
