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Metabolite Safety in Drug Development

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A reference on drug metabolism and metabolite safety in the development phase, this book reviews the analytical techniques and experimental designs critical for metabolite studies. It features case studies of lessons learned and real world examples, along with regulatory perspectives from the US FDA and EMA.

• Reviews the analytical techniques and experimental designs critical for metabolite studies
• Covers methods including chirality, species differences, mass spectrometry, radiolabels, and...