The Science and Regulations of Naturally Derived Complex Drugs

  • Ram Sasisekharan
  • Sau L. Lee
  • Amy Rosenberg
  • Larry A. Walker

Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 32)

Table of contents

  1. Front Matter
    Pages i-vi
  2. Larisa C. Wu, Andre Raw, Werner Knöss, Michael Smith, Wei-Dong Zhang, Y. S. Bedi et al.
    Pages 17-44
  3. Tai-Ping Fan, Yingli Zhu, Christine Leon, Gerhard Franz, Andreas Bender, Xiaohui Zheng
    Pages 59-77
  4. Marco Guerrini, Timothy R. Rudd, Edwin A. Yates
    Pages 115-137
  5. Sarah Rogstad, Michael Boyne, Ashley Ruth
    Pages 139-155
  6. Suman Chandra, Donald Stanford, Edward Fletcher, Larry A. Walker
    Pages 175-190
  7. Yuanyuan Zhu, Fuming Zhang, Robert J. Linhardt
    Pages 191-206
  8. Daniel S. Marsman, Amy L. Roe
    Pages 207-217
  9. Roshni Rao, Daniela Verthelyi
    Pages 219-244
  10. Jinhui Dou, Julie Beitz, Robert Temple
    Pages 245-264
  11. Melissa Jacob, Xing-Cong Li, Larry A. Walker
    Pages 297-310
  12. Rahul Raman, Zachary Shriver, Thomas Clark, Ram Sasisekharan
    Pages 311-327
  13. Back Matter
    Pages 329-331

About this book


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.


complex mixtures toxicity immunogenicity drug manufacturing single agent drug plant-derived natural products

Editors and affiliations

  • Ram Sasisekharan
    • 1
  • Sau L. Lee
    • 2
  • Amy Rosenberg
    • 3
  • Larry A. Walker
    • 4
  1. 1.Department of Biological EngineeringKoch Institute of Integrative Cancer Research, Massachusetts Institute of TechnologyCambridgeUSA
  2. 2.Office of Pharmaceutical Quality, Center for Drug Evaluation and ResearchFood and Drug AdministrationSilver SpringUSA
  3. 3.Office of Pharmaceutical Quality, Center for Drug Evaluation and ResearchFood and Drug AdministrationSilver SpringUSA
  4. 4.Director Emeritus, National Center for Natural Products Research, School of PharmacyUniversity of MississippiOxfordUSA

Bibliographic information

  • DOI
  • Copyright Information American Association of Pharmaceutical Scientists 2019
  • Publisher Name Springer, Cham
  • eBook Packages Biomedical and Life Sciences
  • Print ISBN 978-3-030-11750-4
  • Online ISBN 978-3-030-11751-1
  • Series Print ISSN 2210-7371
  • Series Online ISSN 2210-738X
  • Buy this book on publisher's site