Clinical Pharmacology: Current Topics and Case Studies /
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| Format: | eBook |
| Language: | English |
| Published: |
Vienna :
Springer Vienna : Imprint: Springer,
2010.
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| Edition: | 1st ed. 2010. |
| Subjects: |
Table of Contents:
- 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.