Safety Pharmacology in Pharmaceutical Development : Approval and Post Marketing Surveillance, Second Edition
Shayne C. Gad
Bok Engelsk 2012 · Electronic books.
| Annen tittel | |
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| Medvirkende | Gad, Shayne C. (Contributor)
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| Utgitt | Hoboken : : Taylor and Francis, , 2012.
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| Omfang | 1 online resource (199 p.)
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| Utgave | 2nd ed.
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| Opplysninger | Description based upon print version of record.. - 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. - Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect. These effects often present a hazard-particularly in individuals with compromised or limited organ system functions.Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Surveillance, Second Edition covers safety pharmacology from the regulatory requirements down to the studies that must be done to justify them. Using the author's more than 30 years of direct experience, the book incorporates tricks an
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| Emner | Analytical, Diagnostic and Therapeutic Techniques and Equipment
Anthropology, Education, Sociology and Social Phenomena Drug Approval Drug Discovery Vis mer... Drug Evaluation, Preclinical
Drug and Narcotic Control Evaluation Studies as Topic Investigative Techniques Legislation, Drug Product Surveillance, Postmarketing Social Control, Formal Social Sciences Sociology Toxicity Tests Drugs -- Safety measures. Drugs -- Toxicology. Health & Biological Sciences Legemiddelutvikling Public Health Toksikologi Toxicology & Public Health |
| Sjanger | |
| Dewey | |
| ISBN | 9781439845677
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