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  • Book
    Ram Sasisekharan, [and 3 others], editors.
    Summary: 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.

    Contents:
    Evolving Challenges in Developing Naturally-Derived Complex Mixtures into Drugs: U.S. Experience and Perspective
    Regulatory Landscapes for Approval of Naturally-derived Complex Mixture Drugs
    Complex Natural Product Heparin: Biosynthesis, Biology and Application via Synthetic Heparins
    Traditional Chinese Medicine Herbal Drugs: From Heritage to Future Developments
    Analytics on Farm-Dust Extract for Development of Novel Strategies to Prevent Asthma and Allergic Disease
    Analytical Tools for Physicochemical Characterization and Fingerprinting
    NMR in the Characterization of Complex Mixture Drugs
    Mass Spectrometry in the Characterization of Complex Drugs
    Scientific Considerations in the Approval of Complex Generi
    Raw Materials Production and Manufacturing Process Control Strategies
    Heparin Contamination and Issues Related to Raw Materials and Controls
    Pharmacology and Toxicology Concerns of Impurities
    Immunogenicity risks for Naturally Derived Complex Drugs
    Development of Plant-Derived Mixtures as Botanical Drugs: Clinical Considerations
    A Totality-of-Evidence Approach to Ensuring Therapeutic Consistency of Naturally Derived Complex Mixtures
    Economic Considerations for Complex Mixture Drugs
    Drug Discovery from Complex Mixtures: Serendipity, Screening and Characterization
    Integrated Approach for Characterization of Highly Heterogeneous Drugs.
    Digital Access Springer 2019