Publications by authors named "N S Handler"
Objective: To evaluate the safety of an abbreviated methacholine challenge test (MCT) protocol in children.
Study Design: This prospective, observational study enrolled children aged 6 through 18 years referred for the MCT. The abbreviated protocol was initiated with a methacholine dose of 0.
Article Synopsis
- Regulatory authorities require stability data for drug approval, but traditional analyses are often lengthy and expensive.
- This study introduces a sustainable mechanochemical method for stress-testing five common antihypertensive drugs in the sartan family to create realistic degradation profiles.
- By using high-resolution mass spectrometry, researchers detected impurities and identified significant degradation products within just 15-60 minutes of ball milling, underscoring the method's effectiveness and relevance for solid-state drug stability testing.
Article Synopsis
- Various national and international guidelines, notably ICH Q1-Q14, exist to ensure the efficacy, safety, and quality of drugs during their lifecycle.
- Regular audits, updates, and inspections are crucial to maintaining compliance with these complex regulatory standards, despite the occurrence of drug recalls aimed at protecting patient health.
- The review highlights common reasons for drug recalls, focusing on quality issues like degradation and contamination, with discussions on APIs, excipients, and emerging challenges in drug quality.
The long-term stability of an active-pharmaceutical ingredient and its drug products plays an important role in the licensing process of new pharmaceuticals and for the application of the drug at the patient. It is, however, difficult to predict degradation profiles at early stages of the development of new drugs, making the entire process very time-consuming and costly. Forced mechanochemical degradation under controlled conditions can be used to realistically model long-term degradation processes naturally occurring in drug products, avoiding the use of solvents, thus excluding irrelevant solution-based degradation pathways.
View Article and Find Full Text PDFA method for forced oxidative mechanochemical degradation of active pharmaceutical ingredients (APIs) using clopidogrel hydrogensulfate as a model compound is presented. Considerable and selective formation of degradants occurs already after very short reaction times of less than 15 minutes and the nature of the products is strongly dependent on the used oxidant.
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