Adverse Drug Reactions: A Practical Guide to Diagnosis and Management

This text will be of enormous value to anyone involved in the monitoring and investigation of adverse medical events occurring during the clinical trials, or during the post marketing period of a drug. The book reviews the biochemical and physiological abnormalities in each of the body’s organ systems and helps the investigator decide if the problem is of drug–induced origin. Most of the information is presented as a series of observations with accompanying questions which should be addressed in order to make an accurate diagnosis. Easy–to–read with useful flow charts for the management of adverse drug events and examples of specific report forms, this text will be of interest to all those involved in drug monitoring in clinical medicine, pharmaceutical companies, contract research organisations or regulatory authorities.

Spis treści:
Partial table of contents:
DIAGNOSIS AND MANAGEMENT OF ADVERSE DRUG REACTIONS.
Liver Test Abnormalities (G. Danan).
Abnormal Hematologic Values (P. Solal–Celigny).
Acute Renal Failure (E. Rothschild).
Respiratory Disorders (M. Fournier).
Neurological and Muscular Disorders.
Abnormal Blood Pressure.
Cardiac Disorders.
Psychiatric Disorders (C. Peretti).
Adverse Drug Reactions in HIV–Seropositive Patients (C. Benichou, et al.).
REGULATORY AND TECHNICAL ISSUES.
International Reporting Requirements for Adverse Drug Events (E. Weidmann).
Harmonization of International Reporting of Safety Information for Marketed Drugs: The Proposals of the CIOMS Working Groups I and II (C. Benichou).
A New Method for Causality Assessment: RUCAM (C. Benichou G. Danan).
Appendix.
Index.

Okładka tylna:
This text will be of enormous value to anyone involved in the monitoring and investigation of adverse medical events occurring during the clinical trials, or during the post marketing period of a drug. The book reviews the biochemical and physiological abnormalities in each of the body’s organ systems and helps the investigator decide if the problem is of drug–induced origin. Most of the information is presented as a series of observations with accompanying questions which should be addressed in order to make an accurate diagnosis. Easy–to–read with useful flow charts for the management of adverse drug events and examples of specific report forms, this text will be of interest to all those involved in drug monitoring in clinical medicine, pharmaceutical companies, contract research organisations or regulatory authorities.