Page - (000109) - in Biomedical Chemistry: Current Trends and Developments

majority of pharmacokinetic samples from clinical studies, and the issues of selectivity and specificity should not pose a major concern for the majority of NCEs at this stage. However, other elements associated with LC/MS assays have to be assessed, including the matrix effect, ion suppressing effect and, in the event of selective ion monitoring (SIM), the generation of a common m/z ion for quantification of multiple peaks (Srinivas 2008). It is also important to emphasize that the number of samples increases significantly in the later phases II/III and IV clinical trials and high-throughput, although desirable, may not be the best choice as compared to improving analytical efficiency. At these stages, advantages can be found in automating the bioanalytical process using fast, sensitive and reproducible chromatography with detection and data-capturing capabilities that lead with high amount of data. In the next section, some strategies within this scope will be outlined. 2.1.4 Bioanalysis & Pharmacokinetics, a Synergistic Partnership on DDD In the world of DDD, speed is essential to ensure a competitive position and success in the highly-competitive life sciences marketplace. Therefore, it is important to employ innovative thinking in all areas of DDD and identify laboratory technologies/methodologies that reduce the cycle time from milestone to milestone in conformation with all the requirements laid out for a regulated environment. To address this challenge, besides the advances observed in the HTS in vitro and in vivo methodologies broached in section 1.2, high-throughput bioanalysis has been continuously designed and refined to improve the speed, quality and efficiency necessary to support the increasing number of samples from ADME/pharmacokinetic studies. Table 2.1.6 represents the flexibility in today’s number and types of hyphenated bioanalytical techniques, providing several recent bioanalytical techniques employed to investigate the pharmacokinetics of NCEs in all stages of DDD programs. Study objectives, sample preparation and validation parameters evaluated are also summarized therein. As expected, samples obtained from in vitro and in vivo are