Evaluation of the Effect of Risankizumab on the Pharmacokinetics of Cytochrome P450 Substrates in Patients with Moderately to Severely Active Ulcerative Colitis or Crohn's Disease.

Background And Objective: The objective of this study was to characterize the effects of risankizumab on the pharmacokinetics of cytochrome P450 (CYP) 1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A substrates in patients with moderately to severely active Crohn's disease (CD) or ulcerative colitis (UC) using a cocktail approach.

Methods: Patients with CD or UC (n = 20) received single doses of probe substrates for CYP1A2 (caffeine 100 mg), CYP2C9 (warfarin 10 mg), CYP2C19 (omeprazole 20 mg), CYP2D6 (metoprolol 50 mg), and CYP3A (midazolam 2 mg) before and after intravenous infusions of risankizumab 1800 mg once every 4 weeks for four doses. Serial blood samples were collected for determination of concentrations of the CYP probe drugs and metabolites with and without risankizumab.

Clinical Bridging From Prefilled Syringe to On-body Injector for Risankizumab in Crohn's Disease.

Purpose: This article describes the clinical development bridging strategy and key data to support the marketing application of the risankizumab on-body injection (OBI) system for the treatment of moderately to severely active Crohn's disease (CD), even though the OBI was not evaluated directly in the pivotal Phase III studies in CD.

Methods: Three studies were conducted as part of the clinical bridging strategy. The pilot pharmacokinetics (PK) study was a Phase I, single-dose, 4-arm, open-label, randomized, parallel-group exploratory PK and tolerability study that assessed the effect of rate and volume of administration on the bioavailability (BA) of risankizumab and the extent of injection site-related pain after subcutaneous (SC) administration in healthy subjects.

A new approach to IT security.

More than 60 percent of healthcare data breaches occur due to the loss, theft, or misuse of portable devices. Using a common application programming interface across applications and platforms to build and enforce object-level controls in information itself can help providers better protect ePHI and other types of digital data. Information objects can be engineered to be decrypted only when a legitimate user on a known device using an approved application opens them, and to control what the user can do with the information.

Nutritional strategies and growth in extremely low birth weight infants with bronchopulmonary dysplasia over the past 10 years.

Objective: Changes in nutritional strategies over the past decade have been shown to improve postnatal growth in extremely low birth weight (ELBW) infants. We showed 10 years ago that the majority of these ELBW infants with bronchopulmonary dysplasia (BPD) suffer postnatal growth failure. We theorized that recent changes in nutritional support strategies would positively affect growth outcomes in ELBW infants with BPD.