Method Development and Evaluation

Matrix SRM s, Matrix SRM s can be used for a variety of functions. Taylor (71) reviewed the uses of matrix standards, which Include (a) method development and evaluation, (b) establishment of measurement traceability, and (c) assurance of measurement compatibility. During certification of these matrix SRM s, the selectivity of fluorescence... 

E. R. Kennedy, T. J. Fischbach, R. Song, R M. Eller, and S. A. Shulman, Guidelines for Air Sampling and Analytical Methods Development and Evaluation. Cincinnati NIOSH, USDHH, publication no. 95-117, 1995. 

Numerous methods have been used in PS As for estimating HEPs and other methods are emerging, several of which were developed and evaluated by the NRC. This section describes veiy briefly the methods presented in Table 4,5.1. 

Weston, L. M., D.W. Whitehead, and N. L.Graves, Recovery Actions in PRA for the Risk Methods Integration and Evaluation Program (RMIEP) Volume I Development of the Databascd Method, June 1987. 

HART J D and SCOTT K J (1995) Development and evaluation of an HPLC method for the analysis of carotenoids in foods and the measurement of carotenoid content of vegetables and fruits commonly consumed in the UK. Food Chem. 54(1) 101-111. 

Kirschbanm, 1. et al.. Development and evaluation of an HPLC-DAD method for determination of synthetic food colorants, Chromatogr. Suppl., 57, 115, 2003. 

G.T Wemimont and W. Spendley, Use of Statistics to Develop and Evaluate Analytical Methods, Association of Official Analytical Chemists, Arlington, VA (1985). 

The abundance of crystallographic information on the 3D structure of protein kinases, including knowledge of receptor-ligand complexes, has seen protein kinases feature consistently in datasets employed to both develop and evaluate methods for receptor-based screening. Indeed, the vast majority of literature surrounding protein kinases and receptor-based in silico... 

Horuk R. Development and evaluation of pharmacological agents targeting chemokine receptors. Methods 2003 29(4) 369-375. 

Much of the methods development and validation efforts in the past have been focused on evaluation of immunosuppression and contact or dermal sensitization. Currently available animal models and assays are not valid to assess the potential for systemic hypersensitivity and, at this time, reliable models to assess autoimmunity are not available. 

Horne R and Weinman J (1999) Patients beliefs about prescribed medicines and their role in adherence to treatment in chronic physical illness. J Psychosom Res 47 555-567 Horne R, Weinman J, Hankins M (1999) The beliefs about medicines questionnaire The development and evaluation of a new method for assessing the cognitive representation of medication. Psychol and Health 14 1-24... 

Corti G, Maestrelli F, Cirri M, Zerrouk N, Mura P (2006) Development and evaluation of an in vitro method for prediction of human drug absorption II. Demonstration of the method suitability. Eur J Pharm Sci 27 354-362. 

A PDA detector provides UV spectra of eluting peaks in addition to monitoring the absorbance of the HPLC eluent like the UVA is absorbance detector. It is the preferred detector for testing impurities and for method development. PDA facilitates peak identification during methods development and peak purity evaluation during method validation. Detector sensitivity was an issue in earlier models but has improved significantly (more than ten-fold) in recent years. ... 

Other chromatographic systems snch as DryLab 2000 Pins from LC Resonrces (http //www.lcresources.com) incorporate aspects of method development and validation throngh simnlation software combined with actnal experiments to determine optimal operating conditions. This system is designed to generate efficient method development and method optimization experiments. Resnlts from these experiments can be nsed for the evaluation of robusmess as part of the validation for methods developed using this type of software. 

Method development and optimization are started with review of the currently available methods within the company or in literature. Available methods are used as a starting point and evaluated against the method requirements set in the method definition. If necessary the method is optimized or redeveloped in order to fulfill the requirements. DOE tools (response surface design) are preferentially applied to obtain the best optimal conditions in terms of robustness. Application of DOE methodology is not new in chromatography and DOE is frequently applied also for enantiomeric separations in Especially in... 

The method development and optimization phase is completed with test method description drafted according to the method development results. The following method evaluation tests will continue with direct involvement of the customer (receiving laboratory). The goal is to check whether the developed late phase method performs adequately in different labs. 

Wemimont, G. (1969), Development and Evaluation of Standard Test Methods, The Role of Statistical Design of Experiments, Materials Research Standards, 9(9), 8-21. 

Madsen, K.G. et al. (2007) Development and evaluation of an electrochemical method for studying reactive phase-I metabolites correlation to in vitro drug metabolism. Chemical Research in Toxicology, 20 (5), 821-831. 

Fernandes, J. B., Griffiths, D. W., Bain, H., Fernandes, F. A. N. (1996). The development and evaluation of capillary electrophoretic methods for the determination of the major phenolic constituents of potato Solanum tuberosum) tubers. Phytochem. Analysis, 7, 253-258. 

Subsequently, based on this fundamental knowledge, it is further helpful to define, develop, and evaluate conservation concepts, materials, measures, methods, and techniques of intervention (Scheme 1.2). Analytical control of the intervention... 

The examples presented in this paper are based on results of our laboratory method development and validation studies. These studies, performed at both SRI International and Arthur D. Little, Inc., were supported by the National Institute for Occupational Safety and Health (NIOSH) from 1974 to 1979. In an effort to provide validated sampling and analytical methods for determining worker exposure to toxic substances, we validated existing methods when possible and developed and validated new procedures when no methods were available. Evaluation and testing of solid sorbents played a major role throughout this work ( 1). 

---