(PDF) Specification of Drug Substances and Products: Development and Validation of Analytical Methods 2nd Edition Free

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2
Description
Specification of Drug Substances and Products
Development and Validation of Analytical Methods,
Second Edition, presents a comprehensive and
critical analysis of the requirements and
approaches to setting specifications for
new pharmaceutical products, with an emphasis on
phase-appropriate
development, validation of analytical methods,
and their application in practice. This
thoroughly revised second edition covers topics
not covered or not substantially covered in the
first edition, including method development
and validation in the clinical phase, method
transfer, process analytical technology, analytica
l life cycle management, special challenges with
generic drugs, genotoxic impurities, topical
products, nasal sprays and inhalation
products, and biotechnology products. The book's
authors have been carefully selected as former
members of the ICH Expert Working Groups charged
with developing the ICH guidelines, and/or
subject-matter experts in the industry, academia
and in government laboratories.Presents a
critical assessment of the application of ICH
guidelines on method validation and
specification settingWritten by subject-matter
experts involved in the development
and application of the guidelinesProvides a
comprehensive treatment of the analytical
methodologies used in the analysis, control and
specification of new drug substances and
productsCovers the latest statistical
approaches (including analytical quality by
design) in the development of specifications, meth
od validation and shelf-life prediction
3
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Description
Specification of Drug Substances and Products
Development and Validation of Analytical
Methods, Second Edition, presents a comprehensive
and critical analysis of the requirements and
approaches to setting specifications for new
pharmaceutical products, with an emphasis on
phase-appropriate development, validation of
analytical methods, and their application in
practice. This thoroughly revised second edition
covers topics not covered or not substantially
covered in the first edition, including
method development and validation in the clinical
phase, method transfer, process analytical
technology, analytical life cycle management,
special challenges with generic drugs, genotoxic
impurities, topical products, nasal sprays and
inhalation products, and biotechnology products.
The book's authors have been carefully selected
as former members of the ICH Expert Working
Groups charged with developing the ICH
guidelines, and/or subject-matter experts in the
industry, academia and in government laboratories.
Presents a critical assessment of the application
of ICH guidelines on method validation
and specification settingWritten by
subject-matter experts involved in the
development and application of the guidelinesProvi
des a comprehensive treatment of the analytical
methodologies used in the analysis, control and
specification of new drug substances and
productsCovers the latest statistical
approaches (including analytical quality by
design) in the development of specifications,
method validation and shelf- life prediction
6
(PDF) Specification of Drug Substances and
Products Development and Validation of
Analytical Methods 2nd Edition Free