Drug Development Value Chain

Guidance for industry for bioanalysis exists from the U.S. FDA. Bioanalytical method validation states that "Selective and sensitive analytical methods for the quantitative evaluation of drugs and their metabolites (analytes) are critical for the successful conduct of preclinical and/or biopharmaceutics and clinical pharmacology studies" [10]. Figure 6.15 lists five issues for bioanalysis; discovery, development, methods, sensitivity and specificity, and assay validation. Development of bioanaytical methods starts in discovery stage in an early more rudimentary form and evolves through drug development in overall quality and detail of the procedures. Bioanalytical method validation includes all of the procedures that demonstrate that a particular method used for quantitative measurement of analytes in a given biological matrix, such as blood, plasma, serum, or urine, is reliable and reproducible for the intended use. The fundamental parameters for this validation include (1) accuracy, (2) precision, (3) selectivity, (4) sensitivity, (5) reproducibility, and (6) stability. Validation involves documenting, through the use of specific laboratory investigations, that the performance characteristics of the method are suitable and reliable for the intended analytical applications. The acceptability of analytical data corresponds directly with the criteria used to validate the method. These analyses must be designed to be able to be conducted by any technician trained in the discipline.

Also, the methods above apply to bioanalytical procedures such as gas chromatography (GC), high-pressure liquid chro-matography (LC), and combined GC and LC mass spectro-metric (MS) procedures such as LC-MS, LC-MS-MS, GC-MS, and GC-MS-MS performed for the quantitative determination of drugs and/or metabolites in biological matrices such as blood, serum, plasma, or urine.

Biological products pose additional challenges in bioanalyti-cal development because of their nature; that is, mostly proteins, which have quite complex structures, are processed differently

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