Pharmaceutical Drug Analysis

This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments – particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics.

This handbook is unique in its comprehensive coverage of the subject and focus on practical applications in diverse fields. It includes methods for sample preparation, the role of certified reference materials, calibration methods and statistical evaluation of the results. Problems concerning inorganic and bioinorganic speciation analysis, as well as special aspects such as trace analysis of noble metals, radionuclides and volatile organic compounds are also discussed.

A key component of the overall quality of a pharmaceutical is control of impurities, as their presence, even in small amounts, may affect drug safety and efficacy. The identification and quantification of impurities to acceptable standards presents a significant challenge to the analytical chemist. Analytical science is developing rapidly and provides increasing opportunity to identify the structure, and therefore the origin and safety implications of these impurities, and the challenges of their measurement drives the development of modern quantitative methods.

This thorough book explores some of the most important methods and concepts affecting the quantitative analysis of the transport, targeting, and disposition of chemicals within cells, which in turn impact the macroscopic pharmacokinetics of chemical agents in the whole organism.

The first book in the newly created book series, Computer-Aided Drug Discovery and Design, focuses on the computational aspects of early drug discovery, drug target identification, and validation. It revises current classical paradigms in target and phenotypic-based drug design with still ingrained approximations and concepts and discusses the research in the new network approach concept that include kinetic selectivity and metabolic analysis.

Microscopy plays an integral role in the research and development of new medicines. Pharmaceutical Microscopy describes a wide variety of techniques together with numerous practical applications of importance in drug development. The first section presents general methods and applications with an emphasis on the physical science aspects. Techniques covered include optical crystallography, thermal microscopy, scanning electron microscopy, energy dispersive x-ray spectrometry, microspectroscopy (infrared and Raman), and particle size and shape by image analysis. The second section presents applications of these techniques to specific topics of pharmaceutical interest, including studies of polymorphism, particle size and shape analysis, and contaminant identification. Pharmaceutical Microscopy is designed for those scientists who must use these techniques to solve pharmaceutical problems but do not need to become expert microscopists. Consequently, eachsection has exercises designed to teach the reader how to use and apply the techniques in the book. Although the focus is on pharmaceutical development, workers in other fields such as food science and organic chemistry will also benefit from the discussion of techniques and the exercises.