The Science and Regulations of Naturally Derived Complex Drugs

The Science and Regulations of Naturally Derived Complex Drugs

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...

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Bibliographic Details
Corporate Author: SpringerLink (Online service)
Other Authors: Sasisekharan, Ram (Editor, http://id.loc.gov/vocabulary/relators/edt), Lee, Sau L. (Editor, http://id.loc.gov/vocabulary/relators/edt), Rosenberg, Amy (Editor, http://id.loc.gov/vocabulary/relators/edt), Walker, Larry A. (Editor, http://id.loc.gov/vocabulary/relators/edt)
Format: Electronic eBook
Language:English
Published: Cham : Springer International Publishing : Imprint: Springer, 2019.
Edition:1st ed. 2019.
Series:AAPS Advances in the Pharmaceutical Sciences Series, 32
Subjects:
Pharmaceutical technology.
Pharmacy.
Pharmaceutical Sciences/Technology.
Online Access:Full Text via HEAL-Link
Table of 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. .

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