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Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence - Science, Applications ,and Beyond (Hardcover)
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Pharmaceutical Dissolution Testing, Bioavailability, and Bioequivalence - Science, Applications ,and Beyond (Hardcover)
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Explore the cutting-edge of dissolution testing in an
authoritative, one-stop resource In Pharmaceutical Dissolution
Testing, Bioavailability, and Bioequivalence: Science,
Applications, and Beyond, distinguished pharmaceutical advisor and
consultant Dr. Umesh Banakar delivers a comprehensive and
up-to-date reference covering the established and emerging roles of
dissolution testing in pharmaceutical drug development. After
discussing the fundamentals of the subject, the included resources
go on to explore common testing practices and methods, along with
their associated challenges and issues, in the drug development
life cycle. Over 19 chapters and 1100 references allow practicing
scientists to fully understand the role of dissolution, apart from
mere quality control. Readers will discover a wide range of topics,
including automation, generic and biosimilar drug development,
patents, and clinical safety. This volume offers a one-stop
resource for information otherwise scattered amongst several
different regulatory regimes. It also includes: A thorough
introduction to the fundamentals and essential applications of
pharmaceutical dissolution testing Comprehensive explorations of
the foundations and drug development applications of
bioavailability and bioequivalence Practical discussions about
solubility, dissolution, permeability, and classification systems
in drug development In-depth examinations of the mechanics of
dissolution, including mathematical models and simulations An
elaborate assessment of biophysiologically relevant dissolution
testing and IVIVCs, and their unique applications A complete
understanding of the methods, requirements, and global regulatory
expectations pertaining to dissolution testing of generic drug
products Ideal for drug product development and formulation
scientists, quality control and assurance professionals, and
regulators, Pharmaceutical Dissolution Testing, Bioavailability,
and Bioequivalence is also the perfect resource for intellectual
property assessors.
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