Bioequivalence

Bioequivalence

In-vitro nasal bioequivalence

Off-the-shelf devices avaible for key identified nasal drugs

How to develop a bioequivalent device?

Nemera can perform screening testing with customer formulations and support your registration process

TEST

REQUIRED BY THE FDA

Dose Delivery

Droplet Size Distribution

Spray Pattern

Plume Geometry

Priming / Repriming

Development based on FDA requirements:

bioequivalence

  • Specific program to meet requirements for in-vitro bioequivalence
  • customized testing methodologies with state-of-the-art lab equipment
  • Advanced statistical analysis
We have developed off-the-shelf bioequivalent devices for some key nasal drug products.
Able to offer expertise in market understanding, regulatory affairs, device development and statistical analysis, we are cooperative, committed and responsive device design partner.

Please consult for any question.

Nemera has established a Device Equivalence Program in order to accelerate time-to-market and achieve bioequivalence requirements.