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Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide ...
Most large pharmaceutical process chemistry and manufacturing divisions have devised weighted quantitative schemes to measure the overall attractiveness of a given synthetic route over another. As cost is a major driver, material cost and volume-time output are typically weighted heavily.
An assay (analysis) is never an isolated process, as it must be accompanied with pre- and post-analytic procedures. Both the communication order (the request to perform an assay plus related information) and the handling of the specimen itself (the collecting, documenting, transporting, and processing done before beginning the assay) are pre-analytic steps.
HPLC is widely used for manufacturing (e.g., during the production process of pharmaceutical and biological products), [4] [5] legal (e.g., detecting performance enhancement drugs in urine), [6] research (e.g., separating the components of a complex biological sample, or of similar synthetic chemicals from each other), and medical (e.g ...
Pharmacoepidemiology is the study of the uses and effects of drugs in well-defined populations. [1] [2]To accomplish this study, pharmacoepidemiology borrows from both pharmacology and epidemiology.
Major topics and processes of pathology informatics: Data management from molecular testing, slide scanning, digital imaging and image analysis, networks, databases and telepathology. Pathology informatics is a field that involves the use of information technology, computer systems, and data management to support and enhance the practice of ...
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