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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 ...
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
Pharmaceutical engineering is a branch of engineering focused on discovering, formulating, and manufacturing medication, analytical and quality control processes, and on designing, building, and improving manufacturing sites that produce drugs.
Some companies use the term 'linguistic validation' to refer to the entire process for the translation of PRO measures as described in the 'Principles of Good Practice' (Wild et al. 2005), [3] and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Task Force report (Wild et al. 2009), [4] even if this process does not ...
Data reconciliation is a technique that targets at correcting measurement errors that are due to measurement noise, i.e. random errors.From a statistical point of view the main assumption is that no systematic errors exist in the set of measurements, since they may bias the reconciliation results and reduce the robustness of the reconciliation.
Google Translate is a multilingual neural machine translation service developed by Google to translate text, documents and websites from one language into another. It offers a website interface, a mobile app for Android and iOS, as well as an API that helps developers build browser extensions and software applications. [3]
Stein’s victory coattails will help. Cooper limited his time out of the state because he was worried that Robinson might use legislative tricks to seize power as acting governor.
Pharmaceutics is the discipline of pharmacy that deals with the process of turning a new chemical entity (NCE) or an existing drug into a medication to be used safely and effectively by patients. [1]