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Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
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The Science and Regulations of Naturally Derived Complex Drugs (Hardcover, 1st ed. 2019)
Loot Price: R4,272
Discovery Miles 42 720
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The Science and Regulations of Naturally Derived Complex Drugs (Hardcover, 1st ed. 2019)
Series: AAPS Advances in the Pharmaceutical Sciences Series, 32
Expected to ship within 10 - 15 working days
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This volume in the AAPS Advances series covers various quality,
safety and clinical aspects of drug development that are relevant
to new and/or generic drugs containing a complex mixture of
molecules. Specific topics discussed include: raw materials
sourcing; manufacturing controls; characterization; identification
of critical product quality components and attributes;
identification of impurities, particularly as they bear on toxicity
and immunogenicity; clinical trial study design considerations, and
the regulatory science applications to development of such complex
mixtures. Complex mixtures are challenging to characterize and
analyze using standard methods. Further challenges extend
throughout the product development cycle from raw material control
to clinical study design. The regulatory landscape is rapidly
changing as new types of complex mixtures are introduced into
clinical trials and to the market (e.g., traditional Chinese
medicines and medical marijuana products), while older products are
facing generic competition for the first time (e.g., enoxaparin).
The future outlook for complex generic drug products, as opposed to
the more commonly developed targeted single agent drug products is
not clear. The risks pertaining to lack of a full understanding of
raw material control, process and controls in manufacture, as well
as characterization of a complex mixture were seen vividly during
the heparin crisis of 2008. As such powerful lessons have been
learned about the regulatory science specific to complex products.
The Science and Regulations of Naturally Derived Complex Drugs
addresses the interests among industry, academics, and government
on the issues surrounding the future development of mixtures for
medicinal use.
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