BIOEQUIVALENCE STUDIES
Bioequivalence studies are of great importance and conducting them needs due planning and experience
Through our qualified vendors we reduce the cost of Bioequivalence studies and assist pharmaceutical companies to bring their products to market quickly and on budget, in full compliance with international regulatory requirements.
CRITICAL SUCCESS FACTORS: Adequate Monitoring
One of the critical success factors of our expertise is the adequate monitoring, which includes a qualified monitor, monitoring plan, a monitoring report and follow up.
Here a case study of how the visits could be planned:
STAGE 1
- SIV after CTA approval
- 1° SMV after end of screening
- 2° SMV after the end of Period I dosing
- 3° SMV after the end of Period II dosing
STAGE 2 _ if applicable
- 1° SMV after end of screening
- 2° SMV after the end of Period I dosing
- 3° SMV after the end of Period II dosing
- 4° SMV for the resolution of all the queries
Analitic Monitoring Visit according to Competent Authority Requests
Closure Monitoring Visit