Publications by authors named "Josep Maria Jansat"
Article Synopsis
- The bioanalytical community traditionally uses blank matrices from preclinical animals for method validation, as required by guidelines, but this practice is increasingly being questioned.
- Despite scientific support for using surrogate matrices instead, regulatory bodies remain hesitant to accept them for most cases, only allowing them for rare situations.
- The European Bioanalysis Forum is advocating for the broader acceptance of surrogate matrices, emphasizing ethical considerations and the need for continued discussions, backed by new experimental data.
Tacrolimus, a potent immunosuppressant drug widely used systemically to reduce the risk of organ rejection in transplants, has been repositioned for topical treatment of atopic dermatitis. This work describes the optimization of a new method for the determination of tacrolimus in whole blood after topical administration. Sample treatment consisted of an automated procedure based on protein precipitation followed by solid-phase extraction.
View Article and Find Full Text PDFDimethylfumarate (DMF) has long been used as part of a fixed combination of fumaric acid esters (FAE) in some European countries and is now available as an oral monotherapy for psoriasis. The present investigation determined whether DMF and its main metabolite monomethylfumarate (MMF) interact with hepatic cytochrome P450 (CYP) enzymes and the P-glycoprotein (P-gp) transporter, and was performed as part of DMF's regulatory commitments. Although referred to in the available product labels/summary of product characteristics, the actual data have not yet been made publicly available.
View Article and Find Full Text PDFObjective: To investigate the pharmacokinetics, safety and tolerability of aclidinium bromide 200 μg and 400 μg after a single dose and repeated once-daily doses in younger and elderly patients with moderate or severe chronic obstructive pulmonary disease (COPD).
Methods: Younger (40-59 years; n = 12) and elderly (≥ 70 years; n = 12) patients were treated with aclidinium via the Genuair® inhaler. Patients received once-daily aclidinium 200 μg for 3 days; after a 7-day washout period, patients received once-daily aclidinium 400 μg for 3 days.
Aim: Aclidinium bromide is a muscarinic antagonist in development for the treatment of chronic obstructive pulmonary disease (COPD). This phase I trial in healthy subjects investigated the bronchodilator activity of aclidinium and its ability to reduce methacholine-induced bronchoconstriction.
Methods: This double-blind, partial-crossover study randomized 12 subjects to treatment with single doses of aclidinium (50, 300 or 600 microg) or placebo.