BIOAVAILABILITY/BIOEQUIVALENCE (BA/BE) STUDIES

Bioequivalence main aim is to establish if rate and extent of absorption of the given sample of the drug is comparable with innovators formulation.

DocentPharma also have active association with approved study centers with state of art facilities to perform BA/BE studies. BA/BE studies are carried out in accordance with current GCP as per the ICH guidelines.

DocentPharma advantage for Bioequivalence Services

• Coordination for BE studies (on behalf of formulation manufacture)
• Low cost due to our long-term alliance with CROs
• Providing complete protocol, report and chromatograms
• Handling all pre-registration and post-registration queries

DocentPharma have extensive experience in the field of biostudy management. DocentPharma can:

• Source a Contract Research Organisation (CRO) to carry out either or both the clinical and analytical aspects of a biostudy,
• Carry out pre-study audits of the CRO,
• Provide advice on and review biostudy designs,
• Review & helping in preparation of Protocol for various countries as per respective regulatory authority’s guidance.
• Monitor studies to ensure Good Clinical Practise (GCP) compliance,
• Review of final reports.

Bioequivalence studies format: As per country specific guideline.

For DocentPharma BA/BE services or information, please write email to us: - docent@docentpharma.com