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Active chemical compounds in the pharmaceutical products existing on the market need to be characterized with respect to their properties, or compared to other similar products, already available for direct use. The book describes sampling methodologies, preparation methods, separation possibilities and assay of these compounds at low concentration levels in complex matrixes. The steps covered are taken before launching a new pharmaceutical product on the market for estimating its pharmacokinetic behavior, or before authorizing for marketing of a generic pharmaceutical product.
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Active chemical compounds in the pharmaceutical products existing on the market need to be characterized with respect to their properties, or compared to other similar products, already available for direct use. The book describes sampling methodologies, preparation methods, separation possibilities and assay of these compounds at low concentration levels in complex matrixes. The steps covered are taken before launching a new pharmaceutical product on the market for estimating its pharmacokinetic behavior, or before authorizing for marketing of a generic pharmaceutical product.