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This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities.
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This book presents an essential overview of beta-lactams and their medicinal value and use in the preparation of other biologically active compounds.
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The topics chosen for this volume were selected because they are some of the current development or technological issues facing drug development project teams.
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Much of chemistry, molecular biology, and drug design, are centered around the relationships between chemical structure and measured properties of compounds and polymers, such as viscosity, acidity, solubility, toxicity, enzyme binding, and membrane penetration.
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In the pharmaceutical industry, the incorporation of the disciplines of pharma- kinetics, pharmacodynamics, and drug metabolism (PK/PD/DM) into various drug development processes has been recognized to be extremely important for approp- ate compound selection and optimization.
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Pharmaceutical scientists in industry and academia will appreciate this single reference for its detailed experimental procedures for conducting... Læs mere
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The topics chosen for this volume were selected because they are some of the current development or technological issues facing drug development project teams.
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This book approaches the subject from a mechanistic perspective that pitches the language at a level that is understandable to those entering the field and who are not familiar with its common phrases or complex terms.
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Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents.