Analytical Method Validation for Biopharmaceuticals

Apostoł, Izydor; Krull, Ira S.; Kelner, Drew N.

doi:10.5772/52561

Cited by 12 publications

(7 citation statements)

References 26 publications

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“…The test parameters are established depending on the procedure. A typical system suitability test is to inject a standard and verify that the retention time, dead time, efficiency, tailing, and peak area are those indicated by the manufacturer [67].…”

Section: System Suitability Testingmentioning

confidence: 99%

Validation of Analytical Methods Based on Chromatographic Techniques: An Overview

Péris-Vicente

Esteve‐Romero

Carda‐Broch

2015

Analytical Separation Science

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What Validation Is?The purpose of any analytical method is to provide consistent, reliable, and accurate data. For this reason, the performances and the limitations of the method, as well as the external influences which may modify these features, must be determined prior to its use. Validation plays a major role in achieving this goal [1,2]. The word "validation" comes from the Latin term validus, meaning worth/strong, thus suggesting that something is true, useful, and reliable [3]. The most accurate definition of validation is that provided by ISO 9000:2000 as the confirmation, by means of a thorough examination and obtaining realistic and unequivocal evidences, that the procedure is effectively applicable for its indented purpose [4].Validation is the act of proving that any approach, strategy, experimental procedure, process, laboratory staff, instrumentation, reagents, and room conditions selected for the method will function in a proper way under a fixed set of conditions. Besides, it can be used to individually evaluate the appropriateness of these factors [5]. The validation evaluates the range and conditions of applicability, and checks if every future measurement in routine analysis will provide a concentration of the analyte close enough to the true value [6]. In addition, it can also quantify the degree of coincidence of a measured concentration and the true value, by the calculation of the bias and the uncertainty associated with the result [7]. Therefore, the validation verifies if the method is suitable to be used as a quality control tool and for research support [8]. It is an essential step in method development, which must be implemented by laboratories to prove they can produce analytical data with high reliability [9].The validation consists in the determination of well-defined quality parameters: statistical (selectivity, specificity, calibration curve, linearity, calibration range, accuracy, precision, recovery, uncertainty, limit of detection, limit of quantification (LOQ), decision limit, detection capability, robustness, stability, system suitability, and comparison with other methods) [1,2,10] and operating/ economical (cross contamination, simplicity, analysis time, price per analysis, safety for laboratory staff, and environmental impact) [11,12]. The results from

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Section: System Suitability Testingmentioning

confidence: 99%

Validation of Analytical Methods Based on Chromatographic Techniques: An Overview

Péris-Vicente

Esteve‐Romero

Carda‐Broch

2015

Analytical Separation Science

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“…LOQ is usually a multiple of LOD ( Kakde et al 2008). Standard deviation and slope used in the equations are used to determine LOD and LOQ which is equivalent to instrument sensitivity for the specific analyte, reinforcing that the LOD/LOQ details, are expressed in units of analyte concentration (Apostol et al 2012). It is important to determine sensitivity using analyte amounts near to their detection limits.…”

Section: Limit Of Detection and Limit Of Quantificationmentioning

confidence: 99%

Method development for simultaneous detection of ferulic acid and vanillin using high-performance thin layer chromatography

Hingse

Digole²,

Annapure

2014

J Anal Sci Technol

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Background: A simple, accurate, and reliable high-performance thin-layer chromatography (HPTLC) method was developed for separation and detection of ferulic acid and vanillin. Methods: Separation of ferulic acid and vanillin was carried out on 20 × 10 cm thin layer chromatography (TLC) plates using mobile phase containing toluene/1, 4-dioxan/acetic acid in the ratio 9:2.5:0.4 (v/v). The FA and vanillin were scanned at 320 and 312 nm, respectively. Method was validated for linearity, accuracy, precision, robustness, limit of detection, limit of quantification, and specificity.

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“…Para garantir a qualidade desses produtos, o desenvolvimento e validação de métodos analíticos são essenciais para a indústria como forma de evidenciar a segurança e eficácia exigida. (APOSTOL et al, 2012;GADELHA;COSTA, 2012;BRASIL, 2015).…”

Section: Introductionunclassified