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Books > Medicine > Other branches of medicine > Pharmacology
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Handbook of Preformulation - Chemical, Biological, and Botanical Drugs, Second Edition (Paperback, 2nd edition)
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Handbook of Preformulation - Chemical, Biological, and Botanical Drugs, Second Edition (Paperback, 2nd edition)
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Preformulation studies are the physical, chemical, and biological
studies needed to characterize a drug substance for enabling the
proper design of a drug product, whereas the effectiveness of a
drug product is determined during the formulation studies phase.
Though the two disciplines overlap in practice, each is a
significantly distinct phase of new drug development. Entirely
focused on preformulation principles, this fully revised and
updated Handbook of Preformulation: Chemical, Biological, and
Botanical Drugs, Second Edition provides detailed descriptions of
preformulation methodologies, gives a state-of-the-art description
of each technique, and lists the currently available tools useful
in providing a comprehensive characterization of a new drug entity.
Features: Addresses the preformulation studies of three different
types of new active entities - chemical, biological, and botanical,
which is the latest established class of active ingredient
classified by the FDA Illustrates the activities comprised in
preformulation studies and establishes a method of tasking for drug
development projects Includes extensive flow charts for
characterization decision making Gives extensive theoretical
treatment of principles important for testing dissolution,
solubility, stability, and solid state characterization Includes
over 50% new material
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