Morphologically-Directed Raman Spectroscopy (MDRS) for Generical Nasal Product Bioequivalence
MDRS to Support IVBE Studies
Nasal sprays have been shown to be an effective method of drug delivery. Despite this and due to their complex nature, nasal spray preparations can come with high research and development costs. Both the composition of the Active Pharmaceutical Ingredient (API) and the actual “delivery device” need to be proven to be safe and effective.
Since 2023, the U.S. Food and Drug Administration (FDA) has released a series of bioequivalence guidelines for specific suspended nasal spray products.
The increasing prevalence of infections, rhinitis and allergic conditions, coupled with advancements in drug development and the regulatory acceptance of MDRS technology for establishing in-vitro-bioequivalence (IVBE) of generic nasal spray products, underscores the potential of MDRS technology. By leveraging this approach, manufacturers can accelerate the development and commercialization of generic nasal sprays with minimizing costs, complexity, and associated risks.
Why work with NSF?
- Incomplete ANDA submissions can delay the FDA approval of a generic drug product. Delays can be costly for pharmaceutical companies operating in a fiercely competitive market.
- Our team of scientists and pharmaceutical industry experts has expertise in performing Morphology-Directed Raman Spectroscopy (MDRS) technique combined with a thorough knowledge of the intricate regulatory requirements.
Cras rutrum orci ac lectus porttitor rhoncus
Aenean non nisl et risus tincidunt ornare vel facilisis dolor. Nullam a magna finibus, dignissim orci nec, tristique lorem.
Morbi nec risus vitae velit ullamcorper dapibus sed sit amet purus. Fusce fringilla euismod libero, non ornare nulla ornare vel. Maecenas ultrices diam suscipit purus molestie imperdiet. Etiam dignissim sagittis bibendum.
Etiam volutpat luctus nibh, non accumsan erat pellentesque a. Quisque enim lacus, varius in dapibus in, lobortis sit amet turpis. Cras nec lobortis quam. Sed eget vestibulum mauris. Fusce consequat neque tellus, et laoreet massa vehicula vitae.
Proin tincidunt velit sit amet aliquet faucibus. Sed auctor vulputate nisl vel auctor. Cras rutrum orci ac lectus porttitor rhoncus. Pellentesque habitant morbi tristique senectus et netus et malesuada fames ac turpis egestas.
Duis tempus lorem ornare lacus cursus, eu semper nisl congue. Praesent nulla erat, egestas ac ex non, egestas porttitor nibh. Pellentesque mollis sapien vel mauris malesuada scelerisque. Aenean tincidunt sapien a orci vulputate, in eleifend tellus consequat. Sed finibus, sem in laoreet feugiat, odio ante aliquet leo, suscipit luctus sapien nisl sit amet nunc.
Download Now
