| Contents Notes |
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. Today we witness an eventful time in which the powerful new forces of genomics, information technology and economics are rapidly changing the science and art of medicine. This will require more specialization than ever before. However, there is also an increasing demand for an integrated approach, which is provided by the discipline of Clinical Pharmacology (CP). CP pursues a scientific goal by studying drug action in patients and volunteers, a clinical goal by administering appropriate drug therapy and a regulatory goal by assessing the risk/benefit ratio of drug candidates in drug development and reimbursement. This introduction to current topics of CP covers traditional topics of clinical drug research and trial methodology but also provides insight in current topics like genomics, imaging technology and issues in drug reimbursement. A number of concrete case studies in clinical drug research and development help to give a better understanding of the general principles of CP. |
