Drug Quantification Techniques in Human Plasma - Nair, Sheeba
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Chromatography is one of the important techniques in the current Industry. The combination of two or more component can be quickly separated by this technology. This book brings the basics of Chromatography and research details of applying the chromatography method for molecules with drug and metabolite in separate method and single method, recemic mixtures and sisomers, and applying the validated method for drug quantification for pharmacokinetics studies. There are laid down requirement from each regulatory authority about the method development and validation including from EMA and USFDA…mehr

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Produktbeschreibung
Chromatography is one of the important techniques in the current Industry. The combination of two or more component can be quickly separated by this technology. This book brings the basics of Chromatography and research details of applying the chromatography method for molecules with drug and metabolite in separate method and single method, recemic mixtures and sisomers, and applying the validated method for drug quantification for pharmacokinetics studies. There are laid down requirement from each regulatory authority about the method development and validation including from EMA and USFDA Regulatory, which is applied for the techniques developed and detailed in this Book
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Autorenporträt
La Dra. Sheeba Manoj Nair tiene más de 15 años de experiencia en investigación clínica y desarrollo de drogas. Es experta en los requisitos de calidad, regulación y cumplimiento de la investigación clínica y el desarrollo de medicamentos.