FDA Orange Book 32nd Edition - 2012 (Approved Drug Products With Therapeutic Equivalence Evaluations)

Identifies drug products approved on the basis of safety & effectiveness by the FDA under the Federal Food, Drug, & Cosmetic Act. Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation review) or pre-1938 drugs are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Contains therapeutic equivalence evaluations for approved multi-source prescription drug products.

Identifies drug products approved on the basis of safety & effectiveness by the FDA under the Federal Food, Drug, & Cosmetic Act. Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation review or pre-1938 drugs are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Contains therapeutic equivalence evaluations for approved multisource prescription drug products.

This book describes seven areas in the field of biotechnology operations as practiced by biopharmaceutical firms and nonprofit institutions. Revisions focus upon changes that have occurred in several areas over the past six years, with emphasis on regulatory, biomanufacturing, clinical and technical information, along with processes and guidlines that have added to the discipline. Examples are increased for new technical fields such as cell and tissue engineering. Further, illustrations or figures are added to each chapter to emphasize particular points.

Manual of Clinical Psychopharmacology for Nurses offers a holistic approach to psychopharmacological prescribing from a nursing perspective and is the only text designed especially for Psychiatric Mental Health Advanced Practice Registered Nurses (P.M.H.-A.P.R.N.s). The Manual is grounded in the belief that given their nursing background and their personalized approach to the individual, P.M.H.-A.P.R.N.s are uniquely qualified to offer symptom-based treatment within the context of an individual's medical and psychological care. A comprehensive resource for advanced practice nurses, mental health practitioners, general practitioners, and consumers, this book possesses many useful features, including the following: A logical, easy-to-use format that guides the reader through the most common psychiatric conditions, presenting the diagnostic criteria and neurobiology of the relevant disorder, pharmacological choices and recommendations on monitoring, side effects to consider, and treatment of special populations, including those with medical illnesses. A special chapter devoted to culturally sensitive psychopharmacology that offers information on the role of culture in mental health, wellness, and illness and provides culturally sensitive assessment techniques and other treatment strategies PMH nurses can use to minimize stigma; address health care disparities; and improve patient adherence, satisfaction, and outcomes. A chapter that addresses complementary and alternative pharmacotherapies -- vital because a significant percentage of patients may be using herbal preparations, which present serious implications for the prescribing clinician. Appendices covering drug dosing equivalencies, pharmacogenetics, psychiatric rating scales, and other helpful resources. The core philosophy of the advanced practice nursing field is that health care should be individualized, focusing not only on patients' conditions but also on the effects those conditions have on patients' lives and the lives of their families. The Manual of Clinical Psychopharmacology for Nurses offers readers the most current information on psychopharmacological treatment in an accessible, easy-to-use format grounded in the principles and practices of holistic nursing.