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Pharmacological vs. classical approaches in the design of first in man clinical drug trials.

Cornelis A van den BogertAdam A CohenHubert G M LeufkensJoop M A van Gerven
Published in: British journal of clinical pharmacology (2017)
Trial protocols and investigator's brochures commonly lack pharmacokinetic/PD approaches. Investigators, sponsors and IRBs should require an upfront consideration of pharmacology in these aspects for all FIM trials.
Keyphrases
  • study protocol
  • clinical trial
  • phase iii
  • phase ii
  • randomized controlled trial
  • emergency department
  • drug induced
  • open label