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The use of design space (DS) is a key milestone in the quality by design (QbD) of pharmaceutical processes. It should be considered from early laboratory development to industrial production, in order to support scientists with making decisions at each step of the product's development life. Presently, there are no available data or methodologies for developing models for the implementation of design space (DS) on laboratory-scale spray dryers. Therefore, in this work, a comparison between two different modeling approaches, thermodynamics and computational fluid dynamics (CFD), to a laboratory spray dryer model have been evaluated. The models computed the outlet temperature (Tout) of the process with a new modeling strategy that includes machine learning to improve the model prediction. The model metrics calculated indicate how the thermodynamic model fits Tout data better than CFD; indeed, the error of the CFD model increases towards higher values of Tout and feed rate (FR), with a final mean absolute error of 10.43 K, compared to the 1.74 K error of the thermodynamic model. Successively, a DS of the studied spray dryer equipment has been implemented, showing how Tout is strongly affected by FR variation, which accounts for about 40 times more than the gas flow rate (Gin) in the DS. The thermodynamic model, combined with the machine learning approach here proposed, could be used as a valid tool in the QbD development of spray-dried pharmaceutical products, starting from their early laboratory stages, replacing traditional trial-and-error methodologies, preventing process errors, and helping scientists with the following scale-up.

Background and Objectives : Warts are benign lesions of viral etiology characterized by a hyperkeratotic appearance tending to spread across the skin surface. Various treatments have been proposed to manage this condition, such as acids, imiquimod, photodynamic therapy, cryotherapy, and various lasers. Materials and Methods: In this paper, we describe a combination protocol using CO 2 laser prior to Nd:YAG laser for lesions interesting the palmoplantar areas or dye laser for lesions on other skin surfaces in the management of non-facial warts resistant to traditional therapies. In total, 34 patients with 103 warts suffering from wart infection resistant to traditional therapies treated from 1 January 2019 to 1 June 2020 were retrospectively enrolled at the Dermatological Unit of Magna Graecia University (Catanzaro, Italy). Two dermatologists measured clinical results, classifying lesions with complete resolution, partial resolution, or non-responding. Patients at four months follow-up were asked to evaluate their degree of satisfaction with a visual analog scale (VAS). Results: Almost all patients reported the complete resolution of lesions, with no patient reporting scarring. Five patients reported hypopigmentation in the treated areas. The mean satisfaction level was high. Only three patients experienced a relapse of the condition. Conclusions: Using a vascular laser following a CO 2 superficial ablation of warts may help reduce the risk of scarring and decrease the incidence of relapses for lesions resistant to traditional therapies. Therefore, more extensive studies will be necessary to confirm the obtained results.

Coronavirus disease-19 (COVID-19) is only one of the many possible infectious and non-infectious diseases that may occur with similar imaging features in patients undergoing [ 18 F]-fluorodeoxyglucose ( 18 FDG) monitoring, particularly in the most fragile oncologic patients. We briefly summarise some key radiological elements of differential diagnosis of interstitial lung diseases which, in our opinion, could be extremely useful for physicians reporting 18 FDG PET/CT scans, not only during the COVID-19 pandemic, but also for their normal routine activity., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s) 2020.)