الصفحة 1
الصفحة 1
La scuola dell’atopia = The school of atopy
The need to clarify the current concepts of atopy, which for too long have oscillated between a primitive purely clinical vision and a subsequent purely immunological one, had been ripe for some time. Understanding that the role of immunoglobulins E is not exhaustive and accepting the Solomonic division between intrinsic and extrinsic atopy were the first two fundamental steps. Recent discoveries of the role of innate immunity, and therefore of antimicrobial peptides, have opened fundamental spaces for understanding in atopy and beyond. What now appears clear is that atopy is not the disease of an organ but rather a defect in the membranes that delimit our "self". The fact that these membranes are called skin, intestines, conjunctiva, bronchi or whatever has artificially fragmented the understanding and treatment of a unitary phenomenon. This book seeks to summarize the different experiences but above all to be a stimulus to ensure that medicine focuses constructively on the same target. If this is the case, we will no longer see "religious wars" between scientists and practicing doctors or, even worse, between the different specialists vying for the patient. If atopy, as we believe, is a global problem, it can only be adequately addressed in a multidisciplinary context and in a collaborative atmosphere, not only between doctor and doctor but also between doctor and patient.
Bioequivalence of topical generic products
Bioequivalence (BE) assessment of topical dermatological products is a long standing challenge. The development of generic topical dermatological products has often been hampered due to the limited number of acceptable approaches, which are capable of determining the BE between generic products and reference list products. Currently, except in the case of dermatological corticosteroids, the golden rule to establish the BE of most topical dermatological products still heavily relied on clinical endpoint trials, which are often unreliable, time-consuming and expensive. The regulatory agencies and pharmaceutical industries are forging ahead to the development of new surrogate BE assessment approaches for other topical dermatological products. These promising approaches include dermatopharmacokinetic study (DPK), dermal microdialysis (DMD), near-infrared spectrometry (NIR), and confocal Raman spectroscopy (CRS).
