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Integrated Approach for Characterization of Highly Heterogeneous Drugs

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The Science and Regulations of Naturally Derived Complex Drugs

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

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Abstract

The transformative evolution of the life sciences field is at an important point of convergence with data sciences, which is another dramatically evolving field. The advances in rapid, sensitive, and high-throughput analytical methods and “big data ” approaches (deep sequencing, etc.) have led to an explosion of datasets in life sciences. This rapid accumulation of diverse data necessitates the development of scientific frameworks and concepts borrowing from the evolving data sciences field to make meaningful predictions and practical use of such data. An important practical application of this convergence is providing a scientific framework for regulatory guidance involving characterization of highly heterogeneous molecules that make up active pharmaceutical ingredients of complex drugs . This chapter provides a perspective on developing such a framework for characterization of highly heterogeneous drugs from the standpoint of demonstrating sameness or equivalence with a reference product. Using examples of recently approved generic versions of complex drugs , this chapter presents the concept of “test-points” (terminology used in design of integrated circuit boards) that capture critical relationships between structural attributes of the heterogeneous molecules, the process steps involved in generating the drug product, and the starting reagents or materials.

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Author information

Authors and Affiliations

  1. Department of Biological Engineering, Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, MA, 02139, USA

    Rahul Raman, Zachary Shriver, Thomas Clark & Ram Sasisekharan

Authors
  1. Rahul Raman
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  2. Zachary Shriver
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  3. Thomas Clark
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  4. Ram Sasisekharan
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Corresponding author

Correspondence to Ram Sasisekharan .

Editor information

Editors and Affiliations

  1. Department of Biological Engineering, Koch Institute of Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, MA, USA

    Ram Sasisekharan

  2. Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

    Sau L. Lee

  3. Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

    Amy Rosenberg

  4. Director Emeritus, National Center for Natural Products Research, School of Pharmacy, University of Mississippi, Oxford, MS, USA

    Larry A. Walker

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© 2019 American Association of Pharmaceutical Scientists

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Raman, R., Shriver, Z., Clark, T., Sasisekharan, R. (2019). Integrated Approach for Characterization of Highly Heterogeneous Drugs. In: Sasisekharan, R., Lee, S., Rosenberg, A., Walker, L. (eds) The Science and Regulations of Naturally Derived Complex Drugs. AAPS Advances in the Pharmaceutical Sciences Series, vol 32. Springer, Cham. https://doi.org/10.1007/978-3-030-11751-1_18

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