Published on Wednesday March 19, 2014

Performed a phase I PK and PD study

Smooth Drug Development has performed a phase I PK and PD study of a anticoagulant drug in healthy volunteers.
Anticoagulant use in Russia is limited due to its high price. Therefore, market authorization of this Russian drug produced by a Russian manufacturer will increase drug accessibility to Russian patients.
We understand difficulties connected with phase I study conduct:
  • Intense PK and PD
  • Utilization of laboratory methods, requiring trained of personnel
  • Site selection and subject enrolment challenges
  • Safety challenges
  • Ethical, scientific and regulatory aspects