Bioanalytical method validation: An updated review
نویسندگان
چکیده
منابع مشابه
Analytical Method Validation: An Updated Review
The development of sound Analytical method(s) is of supreme importance during the process of drug discovery, release to market and development, culminating in a marketing approval. The objective of this paper is to review the method development, optimize and validation of the method for the drug product from the developmental stage of the formulation to commercial batch of the product. Method d...
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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...
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The reliability of analytical findings is a matter of great importance in forensic and clinical toxicology, as it is of course a prerequisite for correct interpretation of toxicological findings. Unreliable results might not only be contested in court, but could also lead to unjustified legal consequences for the defendant or to wrong treatment of the patient. The importance of validation, at l...
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ISSN:0975-1459 Bioanalytical method validation includes all of the procedures that demonstrate that a particular method used for a quantitative measurement of analytes in a given biological matrix is selective, sensitive, reliable and reproducible for the intended use. Any method developed for the analysis of analytes in biological fluids must yield consistent results despite the variations in ...
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[1]. In order to evaluate biosimilarity between an innovator and biosimilar product, the FDA recommended a stepwise, riskbased totality of evidence approach. In addition to extensive structural and functional characterization, effort must also be made on preclinical development in terms of animal toxicity studies and the assessment of pharmacokinetics (PK) and immunogenicity. Although there are...
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ژورنال
عنوان ژورنال: Pharmaceutical Methods
سال: 2010
ISSN: 2229-4708
DOI: 10.4103/2229-4708.72226