David Belton discusses the meaning of quality by design in novel respiratory drug delivery device development. He covers how, with more novel devices, prior knowledge may be insufficient for a standard FMEA-style risk analysis, and alternate science-based methods, such as functional mapping and knowledge scoring, can help in achieving QbD.
Heli Chauhan details the myriad challenges facing the OINDP market, with a particular emphasis on nasal spray devices, when it comes to testing products on a mass-production scale, such as a lack of adequate testing equipment and the need to capture accurate data consistently. She goes on to offer a solution in the form of Indizo®, Proveris’ automated nasal spray testing apparatus.
Pascale Farjas, Alain Regard, and Céline Petitcolas discuss the steps taken when designing a nasal spray device for the growing bioequivalence market and the key competencies, including experience with regulations and regulatory agencies in numerous geographic regions, that Nemera can offer throughout the process.