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Appropriate Dose Selection - How to Optimize Clinical Drug Development
Optimal dose individualization has become more important in improving clinical efficacy and safety, given the variability in drug response, e.g., due to concurrent illnesses or co-medications. Therefore, the role of optimal dose finding in early clinical drug development so as to maximize successful clinical use is emphasized. The continued use of biomarkers – based on the (known) pharmacology of the drug and/or biology of the underlying disease – along with exposure–response evaluation throughout all phases of drug development can quantitatively integrate clinical pharmacology knowledge, provide early proof of concept, and help in rational dose selection and rational drug product labeling for clinical use.
Antibiotic pharmacokinetic : Pharmacodynamic considerations in the critically Ill
Provides unique insights into the issues that drive modified dosing regimens for antibiotics in the critically ill. Leading international authors provide their commentary alongside a summary of existing evidence on how to effectively dose antibiotics. Severe infection frequently necessitates admission to the intensive care unit (ICU). Equally, nosocomial sepsis often complicates the clinical course in ICU. Early, appropriate application of antibiotic therapy remains a cornerstone of effective management. However, this is challenging in the critical care environment, given the significant changes in patient physiology and organ function frequently encountered. Being cognisant of these factors, prescribers need to consider modified dosing regimens, not only to ensure adequate drug exposure, and therefore the greatest chance of clinical cure, but also to avoid encouraging drug resistance.
