Nemera.

In-vitro Bioequivalence (IVBE)

In-vitro Bioequivalence (IVBE)

Accelerate your sprint to market with our Device Equivalence Program

Based on FDA requirements, we have established a Device Equivalence Program in order to accelerate time-to-market and achieve in-vitro bioequivalence requirements.

Our main objective is to preselect and propose an appropriate delivery system per identified drug to companies wishing to save time in their nasal spray development programs.

A unique approach to achieve bioequivalence requirements

Our Device Equivalence Program will give you a high confidence level on results of the final product registration thanks to this preliminary bioequivalence study.

Its objective is to propose a delivery system with comparable performance to the branded device in terms of design, patient usage and performance characteristics.

Our Device Equivalence Program is based on FDA requirements:

• Specific program to meet requirements for in-vitro bioequivalence
• Customized testing methodologies with state-of-the-art lab equipment
• Advanced statistical analysis

We can perform in-vitro bioequivalence study and tests with your formulations in our laboratory and support your registration process:

• In-vitro bioequivalence testing
• Different statistical calculations depending on regional needs

We also have developed off-the-shelf bioequivalent devices for some key nasal drug products.

Key Features

• Off-the-shelf devices with IVBE requirements on priming/ re-priming, dose delivery and spray characteristics
• Several pump/ actuator combinations developed

Benefits

• “Fast-track” program meeting FDA IVBE requirements
• Based on track-record SP270+ platform and customized actuators
• In vitro Bioequivalence testing with state-of-the-art lab equipment, from screening tests to registration purposes
• Dedicated program & teams to answer a comprehensive clients’ support, including regulatory and statistics