An alternative Statistical Method to assess In Vitro Bioequivalence of Nasal Products
In vitro, bioequivalence, statistical test, nasal spray, nasal pump, regulatory
This poster focuses on an alternative method to evaluate in-vitro bioequivalence. Bioequivalence is the property wherein two drugs with identical active ingredients or two different dosage forms of the same drug possess similar bioavailability and produce the same effect thus making it an essential step during the development of generic drugs. Despite recommendations and guidelines from Regulatory authorities on the methodology, there is no consensus and statistical approaches differ according to countries; most of the time with limitations.
With this in mind, Nemera has developed a method & protocol in order to increase the power test of the calculation significantly without increasing the sample size in a context of variable drug product.
In this poster, Céline and team propose an alternate statistical method to assess in-vitro bioequivalence for nasal sprays by considering the between-batch variability. They use two RLD (Reference Listed Drug) products – Nasonex® & Flonase® . It is based on the comparison between the mean difference (Reference – Test) and the Reference between-batch variability. This new method relevance is evaluated through simulation and real-case (nasal spray) studies.
With this unique approach of reading statistics, we hope to have a direct beneficial impact on time and costs for our clients.
Aerosol Deposition Profiles In A Nasal Cast Model Using Three Methods Of Administration
RetroNose, nasal administration, nasal deposition, novel, innovative, Covid-19, local drug delivery, systemic drug delivery, vaccine
This poster talks about a new drug delivery concept device that dispenses drug formulation to the nasal cavity: RetroNose®.
The principle of this multi-dose portable device is to deliver a spray through the oral cavity to deposit the drug in the nasal cavity from rear to front. The RetroNose® concept can be compared to the retro nasal olfaction when you eat or drink.
The main objective of this study was to compare the in vitro deposition profiles obtained by a RetroNose® pMDI prototype to a conventional nasal spray pump and a nasal nebulizer for the treatment of chronic rhinosinusitis with corticosteroids. Deposition images produced in the radio labelling study show a more distal and homogeneous deposition of drug in the rhinopharynx and the nasal cavity without lung deposition, in the VCU nasal model when RetroNose® is used. With the two other methods of delivery most of the drug is located in the first few centimetres of the nose. RetroNose® also delivers drug into the sinuses, where a standard nasal pump will be unable to.
With such promising deposition results, compared to conventional nasal sprays and nebulizers, the RetroNose® technology seems encouraging for local, vaccine and systemic nasal drug deliveries.