Quality Risk Management

A Few Lessons from Facilitating or Leading Risk-Based Decision-Making
This paper is based on a fireside chat which took in Technological University Dublin, on June 1st at a conference entitled ‘ICH …
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Controlling Subjectivity in Risk Decision-Making: The Benefits of Multicriteria Decision Analysis
Subjectivity is a necessary part of decision-making under uncertainty and quality risk management. Nevertheless, subjectivity can be controlled through the use of more objectively-based tools of multicriteria decision analysis.
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Controlling Subjectivity in Risk Decision-Making: The Benefits of Multicriteria Decision Analysis
Probability Concepts in Quality Risk Management
Essentially any concept of risk is built on fundamental concepts of chance, likelihood or probability. Although risk is generally a …
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Probability Concepts in Quality Risk Management
The risk of trusting priority numbers
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The risk of trusting priority numbers
A Systematic Approach of Employing Quality by Design Principles: Risk Assessment and Design of Experiments to Demonstrate Process Understanding and Identify the Critical Process Parameters for Coating of the Ethylcellulose Pseudolatex Dispersion Using Non-Conventional Fluid Bed Process
The goal of this study was to utilize risk assessment techniques and statistical design of experiments (DoE) to gain process …
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Quality-by-Design III: Application of Near-Infrared Spectroscopy to Monitor Roller Compaction In-process and Product Quality Attributes of Immediate Release Tablets
The objective of this study is to use near-infrared spectroscopy (NIRS) coupled with multivariate chemometric models to monitor granule …
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Quality-by-Design II: Application of Quantitative Risk Analysis to the Formulation of Ciprofloxacin Tablets
Qualitative risk assessment methods are often used as the first step to determining design space boundaries; however, quantitative …
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Quality by design I: application of failure mode effect analysis (FMEA) and Plackett-Burman design of experiments in the identification of “main factors” in the formulation and process design space for roller-compacted ciprofloxacin hydrochloride immediate-release tablets.
As outlined in the ICH Q8(R2) guidance, identifying the critical quality attributes (CQA) is a crucial part of dosage form development; …
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