Clinical Pharmacology: Current Topics and Case Studies - Müller, Markus; SpringerLink (Online service) (Vienna : Springer Vienna : Imprint: Springer, 2010)
The discipline of Clinical Pharmacology -- Current issues in drug development -- Current issues in drug regulation -- Current issues in drug reimbursement -- Clinical Trials -- Ethics in clinical research -- Good Clinical Practice (GCP) and scientific misconduct -- Phase-I studies and first-in-human trials -- Clinical trials - interventional studies -- Observational studies -- Pharmacokinetics I: PK-PD approaches - antibiotic drug development -- Pharmacokinetics II: 14C-labelled microdosing in assessing drug pharmacokinetics at Phase-0 -- Epidemiology and bio statistics -- Placebo effects and placebo control in clinical trials -- Tools in Clinical Pharmacology -- Tools in clinical pharmacology - imaging techniques -- Current concepts of pharmacogenetics, pharmacogenomics, and the "druggable" genome -- Biomarkers -- Molecular tools in drug research - translational medicine -- Topics in Clinical Pharmacology -- Pharmaceutical drug safety -- Drug interactions medicine -- "Non-chemical" drugs: biologicals, protein therapeutics, vaccines and antisense therapeutics -- Development of Advanced Therapy Medicinal Products - a case for early scientific advice -- Individualized medicine -- Generics, biosimilars, enantiomers and me-toos -- Special situations, market fragmentation I: orphan drugs for rare diseases -- Special situations, market fragmentation II: sex differences -- Special situations III: Medicines for Children.
Keywords: Pharmacology; Pharmacy; Pharmacology/Toxicology.; Pharmacy