Seite - (000086) - in Biomedical Chemistry: Current Trends and Developments

been thoroughly developed to support the high-throughput analysis of samples, including automated online sample preparation with instrumental analysis. It is important to acknowledge that although the high-throughput strategy is well established in all DDD phases, it has different emphases and, consequently, each stage of DDD places different requirements on the bioanalytical assays used to provide information. Briefly, in the initial phases of DDD, straightforward, fast, efficient and high- throughput analytical methods are needed without requiring a fully regulated validation. As the drug candidate moves to development stages, the quality of bioanalytical methods must be improved and their accuracy, precision and reliability are regulated by governmental requisites. Thus, in this chapter the role of pharmacokinetics in each stage of the DDD process and the general characteristics of the bioanalytical methods developed and employed to assess the pharmacokinetic properties of drug candidates will be discussed. Additionally, owing to the recent evolution of the international guidelines on bioanalytical method validation and its increasingly stricter sanctions on drug development and post-marketed studies, a section of this chapter is devoted to overview the most important regulatory guidelines. Moreover, due to the significant technological advances continuously reached in this field, recent bioanalytical strategies that promote greater speed and productivity in bioanalysis during the pharmacokinetic studies are also addressed. 2.1.2 Pharmacokinetics on Drug Discovery and Development Process The pharmacokinetic principles applied during the process of DDD have undergone a revolution in the last decades, as it was understood that the efficacy of any successful drug depends not only on its pharmacological potency but also on its absorption, distribution, metabolism and excretion (ADME) characteristics. Over the time, it became clear that drug candidates with low and/or