New book presents a roadmap for the future development of complex mixtures for medicinal use.
A new volume was recently added to the AAPS Advances in the Pharmaceutical Sciences book series: The Science and Regulations of Naturally Derived Complex Drugs, edited by Ram Sasisekharan, Sau Larry Lee, Amy Rosenberg, and Larry A. Walker. This book 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.
This book specifically covers: 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 develop such complex mixtures.
Complex mixtures are challenging to characterize and analyze using standard methods. Nuclear magnetic resonance imaging, mass spectrometry, and other methods are examined in this book. Further challenges extend throughout the product development cycle from raw material control to clinical study design. Heparin is used as an example
of challenges in raw materials.
Further, 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 of complex generic drug products, as opposed to the more commonly developed targeted single agent drug products, is scrutinized.
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.
Table of Contents for The Science and Regulations of Naturally Derived Complex Drugs:
Evolving Challenges in Developing Naturally-Derived Complex Mixtures into Drugs: U.S. Experience and Perspective
Adam C. Fisher and Sau L. Lee
Regulatory Landscapes for Approval of Naturally-Derived Complex Mixture Drugs
Larisa C. Wu, Andre Raw, Werner Knöss, Michael Smith, Wei-Dong Zhang, Y. S. Bedi, Elaine Gray, and Barbara Mulloy
Complex Natural Product Heparin: Biosynthesis, Biology, and Application via Synthetic Heparins
Po-Hung Hsieh and Jian Liu
Traditional Chinese Medicine Herbal Drugs: From Heritage to Future Developments
Tai-Ping Fan, Yingli Zhu, Christine Leon, Gerhard Franz, Andreas Bender, and
Xiaohui Zheng
Analytics on Farm Dust Extract for Development of Novel Strategies to Prevent Asthma and Allergic Disease
Nathan Stebbins, Erika von Mutius, and Ram Sasisekharan
Analytical Tools for Physicochemical Characterization and Fingerprinting
David A. Keire
NMR in the Characterization of Complex Mixture Drugs
Marco Guerrini, Timothy R. Rudd, and Edwin A. Yates
Mass Spectrometry in the Characterization of Complex Drugs
Sarah Rogstad, Michael Boyne, and Ashley Ruth
Scientific Considerations in the Approval of Complex Generics
Andre S. Raw and Larisa Wu
Raw Materials Production and Manufacturing Process Control Strategies
Suman Chandra, Donald Stanford, Edward Fletcher, and Larry Walker
Heparin Contamination and Issues Related to Raw Materials and Controls
Yuanyuan Zhu, Fuming Zhang, and Robert J. Linhardt
Pharmacology and Toxicology Concerns of Impurities
Daniel S. Marsman and Amy L. Roe
Immunogenicity Risks for Naturally Derived Complex Drugs
Roshni Rao and Daniela Verthelyi
Development of Plant-Derived Mixtures as Botanical Drugs: Clinical Considerations
Jinhui Dou, Julie Beitz, and Robert Temple
A Totality-of-Evidence Approach to Ensuring Therapeutic Consistency of Naturally Derived Complex Mixtures
Sau L. Lee
Economic Considerations for Complex Mixture Drugs
Sen Lin
Drug Discovery from Complex Mixtures: Serendipity, Screening, and Characterization
Melissa Jacob, Xing-Cong Li, and Larry Walker
Integrated Approach for Characterization of Highly Heterogeneous Drugs
Rahul Raman, Zachary Shriver, Thomas Clark, and Ram Sasisekharan
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AAPS members receive a 25 percent discount off books! Order your copy of The Science and Regulations of Naturally Derived Complex Drugs today with the code AAPS25.