منابع مشابه
Analytical Method Validation
In pharmaceutical industries, the validation of analytical methods is used to demonstrate that the method is fitted for its purpose; it must follow a plan which includes scope, performance characteristics, and acceptance limits. Analytical methods need to be validated or revalidated prior to their introduction into routine analyses (release of batch). The overarching philosophy in current good ...
متن کاملBioanalytical method validation
A syntetic discussion on bioanalytical methods validation is presented from the point of view of regulatory documents, scientific articles and books. The validation parameters are described, together with an example of validation methodology applied in the case of chromatographic methods used in bioanalysis, taking in account to the recent Food and Drug Administration (FDA) guidelines and docum...
متن کاملAnatomic Validation of the Method
An accurate echocardiographic (E) method for determination of left ventricular mass (LVM) was derived from systematic analysis of the relationship between the antemortem left ventricular echogram and postmortem anatomic LVM in 34 adults with a wide range of anatomic LVM (101-505 g). No subject had massive myocardial infarction, ventricular aneurysm, severe right ventricular volume overload or h...
متن کاملMethod validation: A complex concept
Editorial I welcome all to the current issue of Pharmaceutical Methods, and thank all our contributors. The reader will find that many of the articles that are published in the current issue refer to method validation and in particular to the International Conference on Harmonization (ICH) guidelines as the basis for their approach. The ICH was launched in 1990, with the objective of harmonizin...
متن کاملValidation Method for Intelligent Systems
Knowledge incorporated intelligent solving methods are prevailing in practical planning and scheduling because of the large problem size and complex constraints. However, when intelligent methods are used in real applications, it is an important problem to validate that both optimality and response time are at expert level. Turing Test approaches are useful in validating intelligent systems. Ne...
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ژورنال
عنوان ژورنال: Accreditation and Quality Assurance
سال: 2013
ISSN: 0949-1775,1432-0517
DOI: 10.1007/s00769-013-1018-3