Integrating data from the Investigational Medicinal Product Dossier/investigator's brochure. A new tool for translational integration of preclinical effects

Br J Clin Pharmacol. 2018 Jul;84(7):1457-1466. doi: 10.1111/bcp.13529. Epub 2018 May 15.
No abstract available

Keywords: Phase I; clinical trials; drug development, animal models; statistics and study design, methodology; toxicity; toxicology.

Publication types

  • Review

MeSH terms

  • Animals
  • Clinical Protocols / standards
  • Clinical Trials, Phase I as Topic / methods
  • Clinical Trials, Phase I as Topic / standards
  • Drug Evaluation, Preclinical / methods*
  • Drug Evaluation, Preclinical / standards
  • Drugs, Investigational / administration & dosage*
  • Drugs, Investigational / adverse effects
  • Drugs, Investigational / pharmacokinetics
  • Humans
  • Models, Animal
  • Pamphlets*
  • Pharmaceutical Research / methods
  • Pharmaceutical Research / standards
  • Risk Assessment / methods
  • Risk Assessment / standards
  • Translational Research, Biomedical / methods*
  • Translational Research, Biomedical / standards

Substances

  • Drugs, Investigational