Search results for " method" in Articles / App Notes
Article
Challenges in Analytical Method Development and Validation
The development and validation of analytical methods is crucial in drug development. While the biopharmaceutical industry has had success in reducing risk by incorporating analytical platform technolo…
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Using Quality by Design to Develop Robust Chromatographic Methods
In 2010, the European Federation of Pharmaceutical Industries and Associations (EFPIA) Subteam on Analytical Methods introduced the concept of applying QbD principles to analytical methods (5) where t…
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Design of Experiments for Analytical Method Development and Validation
Recently, more attention has been placed on applying DOE to analytical methods. DOE for analytical methods has three major applications: method development for new methods or those that need improveme…
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Establishing Acceptance Criteria for Analytical Methods
Little, PhD
To control the consistency and quality of pharmaceutical products, analytical methods must be developed to measure critical quality attributes (CQAs) of drug substance/drug product. An…
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Tackling Analytical Method Development for ADCs
Their composition--a biologic linked to a small-molecule cytotoxic, which enables targeted delivery--also creates challenges for analytical method development, both for characterization and lot releas…
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Emerging Therapies Test Existing Bioanalytical Methods
Challenges remain for development of these therapies, particularly in the bioanalytical method approach required. Questions include the following:
· How much of a dosed gene therapy is present in …
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Simplify chromatography method creation
To save time and effort, method creation can be simplified and you can get to the point where you can start the run quicker. Efficient method creation is often about finding useful tips on how to deve…
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Methods Accelerate Biosimilar Analysis
As the foundation in the development of biosimilars is the analytical strategy, this paper reviews effective analytical methodologies available to perform in-depth characterization of both innovator a…
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Article
Generate an Automated Purification Protocol in Three Steps Using Predefined Methods