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Drug Substance/Product Quality Analysis (Quality Assessment)
Multiple analytical studies are required on drug substances/products to maintain the quality during their lifecycle. One key regulatory change that...
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FDA Approaches in Monitoring Drug Quality, Forces Impacting the Drug Quality, and Recent Alternative Strategies to Assess Quality in the US Drug Supply
Since the US Food and Drug Administration (FDA) began monitoring the quality of pharmaceutical manufacturing by enforcing current good manufacturing...
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Quality By Design Approach for Novel Drug Delivery Systems
QbD offers several unique benefits, including deep material and process understanding, flexibility change within the design space without...
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Surface Engineering and Optimizing DepoFoam System: A Robust Quality by Design Approach for Optimal Drug Delivery, Stability, and Quality
PurposeThe study utilized non-ionic polymer macrogol to transform the surface properties of the DepoFoam drug carrier system, develo**...
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Quality Control and Regulatory Landscape of 3D-Printed Drug Products
This chapter provides an overview of the evolving landscape concerning the quality control (QC) and regulatory considerations surrounding 3D-printed...
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Optimizing Process Parameters for Controlled Drug Delivery: A Quality by Design (QbD) Approach in Naltrexone Microspheres
The formulation of microspheres involves a complex manufacturing process with multiple steps. Identifying the appropriate process parameters to...
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A Quality by Design Update on Nano-drug Delivery Systems
The production of nanoparticles is a very promising approach for improving the delivery of hydrophobic drugs due to their unique properties and...
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Formulation of Ceftriaxone Sodium Under the Guidance of Drug Quality Analysis
Ceftriaxone sodium is an antibiotic used clinically.We have developed a strategy for evaluation of the consistency of ceftriaxone sodium for...
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Assessing the quality of life in patients with drug-resistant tuberculosis: a cross-sectional study
BackgroundThis study investigated the current status of the quality of life (QOL) of drug-resistant tuberculosis (DR-TB) patients in Nan**g, China,...
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Microbiological Monitoring in Analysis of Drug Quality
An informational and analytical review regarding microbiological monitoring in the analysis of pharmaceutical product quality is presented. Regulated...
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Development and application of Adverse drug reactions reports QUality Algorithm (AQUA-12) score: a single-centre quality improvement initiative
PurposeTo develop a reliable assessment tool to monitor the quality of adverse drug reaction (ADR) reports and evaluate its performance within a...
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Antibiotic quality and use practices amongst dairy farmers and drug retailers in central Kenyan highlands
Understanding antibiotic use in dairy systems is critical to guide antimicrobial stewardship programs. We investigated antibiotic use practices in...
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Quality of New Domestic Hand Sanitizer Drug Product Manufacturers During COVID-19
The FDA initiated a cross-sectional, statistically based sampling and testing study to characterize the quality of marketed alcohol-based hand...
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Analysis of the Quality of the Drug Ibuprofen According to the Microbiological-Purity and Particle-Size Indicators
Material related to the analysis of the quality according to Microbiological Purity and Particle Size indicators of various dosage forms of ibuprofen...
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Enhancing Drug Management, Cost Savings, and Staff Satisfaction in Anesthesiology: A Quality Improvement Project in a Chinese Tertiary Hospital
IntroductionIn alignment with China’s national directive for improved drug management in anesthesiology, the Affiliated Hospital of Qingdao...
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Drug Abuse
In this chapter, I examine how LBC are vulnerable to drug abuse, supported by existing literature and the constructed conceptual framework. I present...
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Drug Absorption
Drug absorption involves the movement of drug molecules from the site of absorption to systemic circulation and is a prerequisite to observe a...
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Drug-Drug and Food-Drug Interactions of Pharmacokinetic Nature
The most relevant pharmacokinetic mechanisms of drug-drug (DD) and food-drug (FD) interactions are summarized from a perspective that will allow the...
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Research on the Construction of an Intelligent Drug Package Quality Inspection System Based on Polychromatic Sets Theory
This study is based on the digitization of quality management in the manufacturing industry and aims to address issues such as redundancy of quality...
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