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In-Vitro Bioequivalence (IVBE) & CMC Studies

Orally inhaled and nasal drug products (OINDPs) require specialized analytical services to support regulatory in-vitro bioequivalence study requirements. Although major regulatory agencies such as the EMA and U.S. FDA have clearly defined in-vitro requirements for nasal and inhaled drug products, they must be performed in addition to human clinical studies to fully demonstrate comparative bioequivalence of generic drug products. Innovator and generic drugs require many of the same specialized analytical tests to generate data for their Chemistry, Manufacturing and Controls (CMC) sections of their applicable filings. Nanopharm offers all the specialized analytical capabilities needed to support generic IVBE studies and CMC filings for OINDPs. Furthermore, Nanopharm has developed an alternative non-clinical pathway to bioequivalence for generic inhalation products called SmartTrack™.

Nanopharm In-Vitro Bioequivalence (IVBE) & CMC Analytical Services

Nanopharm’s analytical scientists understand the well-defined regulatory filing requirements for in-vitro bioequivalence (IVBE) studies of generic intranasal drug products.

Generic drug product characterization is required to ensure robustness of the drug product and comparability to the innovator product.

Innovator and Generic OINDP development programs are designed to meet the CMC analytical requirements for innovator IND/ANDA/NDA intranasal and inhaled drug products with filing ready data and supporting documentation.

Generic OINDP In-Vitro Bioequivalence (IVBE) Studies

Nanopharm has built comprehensive cGMP analytical capabilities that can meet the well-defined regulatory filing requirements for in-vitro bioequivalence (IVBE) studies of orally inhaled and intranasal drug products.  With a full array of modern and specialized analytical instruments operated by a team of experienced respiratory scientists, Nanopharm can deliver the analytical data and documentation to satisfy today’s IVBE in-vitro test and metric requirements, including the appropriate statistical analysis. Our cGMP laboratories can support the specialized analytical service requirements of inhaled and nasal drug products. Our analysts can also perform pre-bioequivalence studies as well as support drug delivery system and batch selection from Aptar Pharma’s extensive line of advanced intranasal technologies. 

Analytical tests that Nanopharm offers in support of OINDP IVBE studies include single actuation content (SAC), delivered dose uniformity (DDU), droplet size distribution (DSD) by laser diffraction, small particle droplets or aerodynamic particle size distribution by cascade impactor (DISP / APSD), spray pattern (SP) and plume geometries (PG). 

Nanopharm also offers MDRS analysis (measuring particle size distribution of suspensions) and orthogonal dissolution testing, both of which were recently added to the U.S. FDA’s product specific guidances (PSG) for generic nasal spray suspensions. 

We have pioneered an alternative, non-clinical bioequivalence pathway that eliminates the need for costly comparative clinical endpoint studies called SmartTrack™.

Generic Inhaled Drug Product Characterization

Nanopharm’s analytical services can fully characterize inhaled drug products to current regulatory requirements. Available drug product characterizations include resting time effects, temperature cycling, in-vitro dose proportionality, varying flow rate, effect of orientation, effect of storage on particle size, preservative effectiveness and more. Nanopharm is therefore well positioned to be able to perform all testing needed for generic inhalation in-vitro bioequivalence (IVBE) studies as well as analysis for new innovator CMC OINDP filings.

OINDP CMC & Stability Studies

Nasal and inhaled drug products require extensive specialized analytical testing as part of the development process and results must be supportable in their eventual drug filings. Nanopharm is highly experienced in preparing cGMP analytical data and documentation, in filing ready formats. With data and support for the Chemistry, Manufacturing and Controls (CMC) portions of applicable filings, Nanopharm is well positioned to enhance you OINDP development process.  Our analytical scientists can fully characterize the API, formulation, and drug product as well as the device for regulatory filing requirements, including the completion of required ICH stability studies that demonstrate drug product stability and set the shelf life of the product.  Nanopharm’s cGMP analytical laboratories are fully equipped with the state-of-the-art analytical instrumentation as well as the specialized in-vitro techniques needed to fully characterize OINDPs.

Nanopharm In-Vitro BioEquivalence (IVBE) & CMC Analytical Services

As an industry leader in the development of intranasal and inhaled drug products, Nanopharm has built the specialized cGMP analytical capabilities needed to provide the data and documentation needed for generic product in-vitro bioequivalence (IVBE) and for innovator drug CMC filings. Our unwavering dedication to OINDPs means that Nanopharm has the analytical capabilities needed to meet today’s regulatory filing and dossier requirements.