Clinical Pharmacology: Current Topics and Case Studies /

Detalles Bibliográficos
Autor Corporativo: SpringerLink (Online service)
Otros Autores: Müller, Markus. (Editor )
Formato: eBook
Lenguaje:English
Publicado: Vienna : Springer Vienna : Imprint: Springer, 2010.
Edición:1st ed. 2010.
Materias:
Tabla de Contenidos:
  • 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.