Implementation of Patient Reported Outcome Measures (PROMs) in QbD based formulation development in ophthalmology

Abstract

Development of drug delivery systems for chronic disorders needs a complex thinking in order to ensure the quality of the product. A multidisciplinary approach of pharmaceutical technology, regulatory and behavioral sciences on the basis of the Quality by Design methodology can be a proper tool for this to handle formulators’, patients’, and also doctors’ needs in therapy planning in case of chronic ophthalmologic disorders. According to the present state-of-the-art”, patient perceptions are collected in the form of the “Patient Reported Outcome Measurements” during the clinical trials, but no feedback is given to the formulation development in order to take these aspects into consideration when designing a new product. This work aims to link the key performance indicators from patients’ point of view to the pharmaceutical development and show a new approach to product development by evaluating the patient and formulator aspect as critical quality attributes within the classical Quality by Design workflow. This study can be the basis of the formulation design and development of a new ophthalmic formulation as it revealed the patient critical needs and requirement.

The Amalgamation of Risk Assessment Using Quality by Design Principles and Prediction of Regression Models in the Development of Dexmedetomidine-loaded Lipospheres for Intra-articular Administration

“…A concise matrix relating the level of severity and Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs) was prepared. (Table 2) 24 The severity score for the material attributes and process parameters was calculated. (Figure 1a) The relative occurrence and relative severity of the CMAs and CPPs are depicted in Figure b, and the factors with the highest occurrence and severity rate were subjected to further investigation to identify the optimal value of each examined variable using Box-Behnken design.…”

Strategies for development of antimicrobial peptides and proteins

“…After the selection of the proper AMP, the extended Quality by Design (QbD) based development [109] is suggested (Figure 7). After the definition of the Quality Target Product Profile (QTTP), the next step is the initial risk assessment due to the complex interdependency of different factors and a number of possible risks [110,111]. By means of proper quality management tools such as the Ishikawa diagram, the control of the Critical Quality Attributes (CQAs) and the Critical Process Parameters (CPPs) during modification and formulation of AMPs can be tested.…”