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Can I read Safety Pharmacology and Risk Assessment on EtoBox?
Safety Pharmacology and Risk Assessment by Lewis B. Kinter; Jean-Pierre Valentin is a Medicine article available to read on EtoBox.
What is Safety Pharmacology and Risk Assessment about?
Evaluation of experimental drugs in animals for effects on critical organ systems allows identification of functional signals of efficacy and safety that can be subsequently monitored in human clinical trials. The International Conference on Harmonization (ICH), `Guidelines on Safety Pharmacology', finalized in 2000, defined critical organ systems (cardiovascular, respiratory and central nervous system) and functions to be evaluated, and points to consider for study design and conduct. The new Safety Pharmacology guidelines recognise that while in vitro studies of molecular targets (enzymes, receptors, ion channels, etc.) suggest mechanisms by which chemicals might impact organisms, organ functions are complex, integrative, and most usefully evaluated in their totality, in intact and ideally unanesthetized animal models. Signals identified from safety pharmacology studies are candidates for biomarkers, which when established/validated, can enhance cross‐species‐based risk assessments and risk management in clinical trials. This review will briefly trace the origins of modern safety pharmacology and discuss practical issues related to the identification and application of signals ge
Who reads Safety Pharmacology and Risk Assessment?
It is typically read by researchers, students, and practitioners in Medicine.
- Author
- Lewis B. Kinter; Jean-Pierre Valentin
- Publisher
- John Wiley and Sons; Wiley (Blackwell Publishing); Blackwell Publishing Inc.; Wiley (ISSN 0767-3981)
- Published
- 2002
- Language
- EN
- Field
- Medicine (Health Sciences)