TABLE OF CONTENTS The analysis of drugs and their metabolites in biological fluids and pharmaceutical products has an essential role in new drug development and the registration of a new drug for human or animal healthcare. The analytical work that is undertaken may be applied initially to the study of the pharmacokinetics and metabolism of a candidate substance in an animal model or in vitro system, such as isolated cell cultures. Later work requires the analysis of parent drug and active metabolites in human volunteer studies and subsequent clinical trials in patient groups. A good understanding of the metabolism of a drug and pharmacokinetic profile in appropriate groups of patients is essential for a complete understanding of the drug's clinical activity and possible toxicity. In addition, the development of different formulations requires that analytical work be undertaken to ensure that the final product meets the required specifications for bioavailability and safety. Measurement of plasma drug concentrations is also important in the continuing investigation of a drug's therapeutic action and toxicity once the product has been introduced into clinical practice.
Sensitive and specific methods of analysis are an essential requirement for the measurement of all drugs and their metabolites in biological fluids and tissues. The most common approach is that of gas chromatography mass spectrometry and liquid chromatography mass spectrometry.
In most cases, blood is the most appropriate specimen of biological fluid to be collected for the analysis of drugs and their...
