The Science and Regulations of Naturally Derived Complex Drugs

Language: English

Published by Springer International Publishing Mai 2019, 2019

3030117502 / 9783030117504

Series: Book 31 of 38 - AAPS Advances in the Pharmaceutical Sciences

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Seller: BuchWeltWeit Ludwig Meier e.K., Bergisch Gladbach, GermanyBuchWeltWeit Ludwig Meier e.K.

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This item is printed on demand - it takes 3-4 days longer - Neuware -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. 340 pp. Englisch. …

Seller Inventory # 9783030117504

Title
The Science and Regulations of Naturally Derived Complex Drugs
Author
Ram Sasisekharan
Publisher
Springer International Publishing Mai 2019
Publication year
2019
Condition
Neu
Binding
Buch
Language
English
ISBN 10
3030117502
ISBN 13
9783030117504
Item weight
676 grams
Dimensions
241x160x24 mm
Series
Book 31 of 38: AAPS Advances in the Pharmaceutical Sciences

BuchWeltWeit Ludwig Meier e.K.

Bergisch Gladbach, Germany

5-star seller

AbeBooks seller since January 11, 2012

Shipping rates from Germany to U.S.A.

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BuchWeltWeit Ludwig Meier e.K.

Germany