Publications by authors named "H Pappa"
The analytical procedure life cycle (APLC) provides a holistic framework to ensure analytical procedure fitness for purpose. USP's general chapter <1220> considers the validation activities that take place across the entire analytical procedure lifecycle and provides a three-stage framework for its implementation. Performing ongoing analytical procedure performance verification (OPPV) (stage 3) ensures that the procedure remains in a state of control across its lifecycle of use post validation (qualification) and involves an ongoing program to collect and analyze data that relate to the performance of the procedure.
View Article and Find Full Text PDFArticle Synopsis
- A multicenter trial was conducted to compare the effectiveness of tumor necrosis factor inhibitors combined with oral methotrexate versus those without methotrexate in pediatric patients with Crohn's disease.
- The study involved 297 participants, revealing that combination therapy did not significantly improve treatment outcomes for infliximab initiators, but did show a longer time to treatment failure for adalimumab initiators.
- Although combination therapy led to more adverse events overall, it resulted in fewer serious adverse events, with no significant differences reported in patient-reported outcomes of pain and fatigue.
Patients with Crohn's disease often have low bone mineral density and an increased risk of osteoporosis. Although decreased bone formation can be seen at diagnosis, the underlying pathophysiology of suboptimal bone accrual remains poorly understood. We sought to evaluate a novel mechanism affecting osteogenesis in patients with Crohn's disease.
View Article and Find Full Text PDFArticle Synopsis
- - The study investigates the use and effectiveness of antitumor necrosis factor (TNF) biologics in young children diagnosed with very early onset inflammatory bowel disease (VEOIBD) across 25 North American centers from 2008 to 2013, aiming to track treatment initiation and durability over time.
- - Out of 294 children with VEOIBD, 120 started anti-TNF therapy, with a 90% treatment durability at 1 year, which declined to 55% by 5 years, and loss of response was the main reason for discontinuation.
- - The research found that children with Crohn disease had a significantly higher treatment durability than those with ulcerative colitis or IBD unclassified
Recent changes in the pharmaceutical industry have led to significant paradigm shifts in the pharmaceutical quality environment. Globalization of the pharmaceutical industry, increasingly rapid development of novel therapies, and adoption of new manufacturing techniques have presented numerous challenges for the established regulatory framework and quality environment and are impacting the approaches utilized to ensure the quality of pharmaceutical products. Regulators, industry, and standards-setting organizations have begun to recognize the need to rely more on integrated risk-based approaches and to create more nimble and flexible standards to complement these efforts.
View Article and Find Full Text PDF