Η χρήση των δεικτών ικανότητας διεργασίας για την αξιολόγηση των φαρμακευτικών προϊόντων
The use of process capability indices for the evaluation of pharmaceutical products΄ quality
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Abstract
In the modern and strictly regulated environment of the pharmaceutical industry, quality assurance is a critical factor for both patient safety and product effectiveness. The need for accurate and effective tools for continuous monitoring the production process leads to the implementation of statistical process capability indices and advanced quality methodologies such as Six Sigma.
This thesis examines the most important process capability indices such as Cp, Cpk, Cpm, and Cpmk analyzing their properties, estimation methods, and relevance in pharmaceutical manufacturing. Additionally, the Six Sigma methodology is presented, and its contribution to quality and performance optimization is explored.
The theoretical analysis is complemented by an application exploiting simulated medical data related to patients with dementia. Through statistical processing, capability index values are assessed for different treatment regimens, aiming to compare the impact of pharmaceutical intervention on critical biomarkers such as heart rate, blood oxygen level and body temperature.
The study highlights the importance of using statistical process capability indices in the pharmaceutical sector as a quantitative tool for monitoring the variability of critical parameters and supporting decision-making processes that aim at enhancing quality and therapeutic safety.
Postgraduate Studies Programme
Εφαρμοσμένη ΣτατιστικήDepartment
Σχολή Χρηματοοικονομικής και Στατιστικής. Τμήμα Στατιστικής και Ασφαλιστικής ΕπιστήμηςNumber of pages
100Language
GreekCollections
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Αναφορά Δημιουργού-Μη Εμπορική Χρήση-Όχι Παράγωγα Έργα 3.0 Ελλάδα
Αναφορά Δημιουργού-Μη Εμπορική Χρήση-Όχι Παράγωγα Έργα 3.0 Ελλάδα