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