Validation of Bioanalytical Methods (Essay Sample)

Validation of Bioanalytical Methods: A Review Name: Date: Course: Lecturer: University: Introduction Reliability of data generated by bioanalytical methods is paramount. This explains the emphasis put by Karnes, Shiu and Shas in the practice of validating the various bioanalytical methods used in drug discovery and development (1). This papers seeks to review Karnes et al.’s article while critically comparing and contrasting it to other recent publications on the same among which include the specifications by the U.S. Food and Drug Administration on the validation of bioanalytical methods. Intrinsic value, limitation and validity and uniqueness The topic of the article appropriately addresses the content of their paper. The topic is able to give the reader a clear idea of what to expect from the paper and indeed this is what the paper presents. The article is a review paper in which various techniques employed in the validation of bioanalytical methods are critically analyzed. However, the authors argue that the intrinsic value of a technique plays a central role in the process of reviewing standardization techniques, particularly in relation to specificity/selectivity (1). Selectivity revolves around the ability of a method to respond to several chemical entities whether distinguished or not. Specific involves response for just a single analyte. On the other hand, the idea of limitation and validity plays a key role in the process of reviewing the various models employed in analytical calibration curves. The uniqueness of most bioanalytical methods sometimes calls for specific validation criteria (2). However it is evident in Karnes et al.’s review that the literature that had been published by then was not comprehensive enough for purposes of sufficiently developing quality control procedures for use in biopharmaceutical analysis related to drug studies (1). Minimum standards for bioanalytical methods and limitations in determining the effectiveness of a method Although the article seeks to review the various validation techniques, the authors are quick to note that there were limitations in terms of determining the effectiveness of a given method to address the needs of a particular validation project. This is partly caused by the dynamic nature of pharmaceutical science where rules and applications change rapidly. Tiwari and Tiwari add that most bioanalytical methods and techniques are at the cutting edge of technology and hence there is an increasing need for effective validation since (3). Additionally, it is rather difficult to set minimum standards for the various bioanalytical techniques as this would encourage interested parties to only apply the minimum (1, 4, and 3). In as much as there are validation techniques, bioanalytical methods ought to satisfy certain minimum specifications during development (1, 3, and 4). Tiwari and Tiwari also support the idea of minimum standards for development of bioanalytical methods and validation by noting its importance in market approval of bioanalytical methods. Selectivity/ specificity Karnes et al.’s article has since 1991 been an important basis for review of validation techniques for bioanalytical methods (3, 4). The article indicates that the concept of selectivity/specificity is very crucial given that only a few techniques have the ability to respond to only one analyte. Karnes et al. adds that interferences are more problematic especially in cases when handling biopharmaceutical analysis (1). The U.S. Food and Drug Administration points out that there should be evidence showing that the analyte quantified is indeed what was intended (5). Peters and Maurer and Tiwari and Tiwari add that selectivity accounts for the potential presence of metabolites, making the technique very useful for bioanalytical method validation (4, 5). Calibration model Karnes et al. offer a very detailed review of the minimum expectations of the calibration model. They give sufficient specifications on what bioanalytical methods should be able to address (1). However, the concept of linearity comes up and is a critical consideration for the validation process (3). Linearity encompasses assessing the capacity of a technique to give test results that relate directly with concentration of the sample’s analyte. The U.S. Food and Drug Administration supports Karnes et al.’s specifications on the validation of calibration model (5). Peters and Maurer gives details on the analysis of spiked calibration samples and how the resulting responses can be analyzed further graphically, using mathematical models or including statistical analysis of the response functions. Calibration models’ choice affects the reliability of quantification (4). Other validation aspects In addition to selectivity and calibration model, all the other publications cited above review stability, reproducibility, accuracy, precision, recovery, bias and ruggedness just like Karnes et al.’s article yet it was published nearly 20 years before (2), (3), (5) and (4). Recovery revolves around an analyte’s detector response while in precision, interest is focused on the closeness of individual measures. According to the various authors, accuracy aims at measuring the closeness of mean test results as produced by a method to the actual value while in reproducibility, assessment of replicate measu...