Approved drug products with therapeutic equivalence evaluations.

Distributed to depository libraries in microfiche, 198 -2001.Kept up-to-date between editions by monthly cumulative supplements.Mode of access: Internet.Vols. for 1985-198 issued by: U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drugs and Biologics; 198 -1988 by: U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drug Evaluation and Research; 1989- by: U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Management

Guideline on sterile drug products produced by aseptic processing /

"June 1987.""Maintained by Division of Manufacturing and Product Quality (HFN-320), Office of Compliance, Center for Drugs and Biologics, Food and Drug Administration (FDA)."Bibliography: p. 42-43.Mode of access: Internet

The International Society for Bipolar Disorders (ISBD) consensus guidelines for the safety monitoring of bipolar disorder treatments

Journal compilation © 2009 John Wiley & Sons A/S. © 2009 The Authors.ObjectivesSafety monitoring is an important aspect of bipolar disorder treatment, as mood-stabilising medications have potentially serious side effects, some of which may also aggravate existing medical comorbidities. This paper sets out the International Society for Bipolar Disorders (ISBD) guidelines for the safety monitoring of widely used agents in the treatment of bipolar disorder. These guidelines aim to provide recommendations that take into consideration the balance between safety and cost-effectiveness, to highlight iatrogenic and preventive clinical issues, and to facilitate the broad implementation of therapeutic safety monitoring as a standard component of treatment for bipolar disorder.MethodsThese guidelines were developed by an ISBD workgroup, headed by the senior author (MB), through an iterative process of serial consensus-based revisions. After this, feedback from a multidisciplinary group of health professionals on the applicability of these guidelines was sought to develop the final recommendations.ResultsGeneral safety monitoring recommendations for all bipolar disorder patients receiving treatment and specific monitoring recommendations for individual agents are outlined.ConclusionsThese guidelines are derived from evolving and often indirect data, with minimal empirical cost-effectiveness data available to provide guidance. These guidelines will therefore need to be modified to adapt to different clinical settings and health resources. Clinical acumen and vigilance remain critical ingredients for safe treatment practice.Ng Felicity, Mammen Oommen K., Wilting Ingeborg, Sachs Gary S, Ferrier I Nicol, Cassidy Frederick, Beaulieu Serge, Yatham Lakshmi and Berk Michae