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This book describes the role modern pharmaceutical analysis plays
in the development of new drugs. Detailed information is provided
as to how the quality of drug products is assured from the point of
discovery until the patient uses the drug. Coverage includes
state-of-the-art topics such as analytics for combinatorial
chemistry and high-throughput screening, formulation development,
stability studies, international regulatory aspects and
documentation, and future technologies that are likely to impact
the field. Emphasis is placed on current, easy-to-follow methods
that readers can apply in their laboratories.
No book has effectively replaced the very popular text,
Pharmaceutical Analysis, that was edited in the 1960s by Tak
Higuchi. This book will fill that gap with an up-to-date treatment
that is both handy and authoritative.
"Handbook of Modern Pharmaceutical Analysis, Second Edition, "
synthesizes the complex research and recent changes in the field,
while covering thetechniques and technologyrequired for today's
laboratories. The workintegrates strategy, case studies,
methodologies, and implications of new regulatory structures,
providing complete coverage of quality assurance from the point of
discovery to the point of use.
Treats pharmaceutical analysis (PA) as an integral partner to the
drug development process rather than as a service to itCovers
method development, validation, selection, testing, modeling, and
simulation studies combined with advanced exploration of assays,
impurity testing, biomolecules, and chiral separations Features
detailedcoverage of QA, ethics, and regulatory guidance (quality by
design, good manufacturing practice), as well as high-tech
methodologies and technologies from"lab-on-a-chip" toLC-MS, LC-NMR,
and LC-NMR-MS
"
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