Purpose Under ICH Q9 (R1), risk is defined as a function of probability and severity of harm. Although probability may be expressed quantitatively, little empirical evidence exists regarding how EU GMP auditors assess probability in practice. This study explored probability assessment approaches among auditors and the use of qualitative and quantitative methods. Methods A descriptive cross-sectional questionnaire was administe...

Background Zavegepant shares a pharmacological target with oral gepants but has distinct pharmacokinetics and a unique intranasal route. While oral safety profiles are well defined, the real-world impact of the intranasal route on systemic sparing effects remains under-investigated. This study compared the real-world safety profiles of zavegepant and oral gepants. Methods We performed a disproportionality analysis using the FD...

Purpose Chronic non-communicable inflammatory skin disorders involve persistent immune activation, oxidative stress, and impaired repair. Conventional topical agents such as corticosteroids often cause adverse effects with long-term use. Epigallocatechin-3-gallate (EGCG), a potent antioxidant and anti-inflammatory polyphenol, shows therapeutic potential but is limited by poor stability and permeability. Hydroxypropyl methylcel...