Safety pharmacology in pharmaceutical development: approval and post marketing surveillance
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Bibliographische Detailangaben
1. Verfasser: Gad, Shayne C. 1948- (VerfasserIn)
Format: Elektronisch E-Book
Sprache:English
Veröffentlicht: Hoboken CRC Press 2012
Ausgabe:2. ed.
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Beschreibung:Description based upon print version of record
This book covers the regulatory required evaluation and study of the potentially adverse pharmacological effects of new drugs. Coverage ranges from the general regulatory requirements to the specific studies that must be done and how they are performed and interpreted. Based on more than 30 years of direct experience, the author describes tricks and practical insights for making studies work and understanding why they don't. The second edition includes current regulations (US FDA and international--especially Europe and Japan) and updated test methods, interpretation, and science
Front Cover; Contents; Preface; About the Author; Chapter 1: Safety pharmacology: Background, history, issues, and concerns; Chapter 2: Regulatory requirements: ICH, FDA, EMA, and Japan; Chapter 3: Principles of screening and study design; Chapter 4: Cardiovascular system; Chapter 5: Central nervous system; Chapter 6: Respiratory system; Chapter 7: Renal function; Chapter 8: The gastrointestinal system; Chapter 9: The immune system; Appendix A: Acronyms; Appendix B: Laboratories conducting safety pharmacology testing; Back Cover
Beschreibung:1 Online-Ressource (xv, 180 p.)
ISBN:1439845689
9781439845684

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