ABSTRACT

Botanicals, which have been part of human food and medicine for thousands of years, are perceived as being safer than synthetic pharmaceuticals. The global botanical drug market was expected to reach $26.6 billion by 2017. In terms of FDA regulations, botanical drugs are no different from non-botanical products, having to meet the safety and effectiveness standards of a new drug in accordance. This book comprises a complete start-to-end process from drug-idea conception, to drug development process.

Key Features:

  • Provides a complete compendium for botanical drug products
  • Describes what BDP is and how it differs from Pharma, Biopharma, and Nutraceuticals
  • Compiles all critical regulatory steps in a variety of countries
  • Discusses clinical trial management for BDP development and how it differs from conventional chemical-based drugs and biopharmaceutics

    • chapter 12|22 pages

    Evidence-Based Medicine, Safety, and Efficacy

    Clinical Trial Management in Botanical Drug Products
    ByAva Milani, Yashwant Pathak

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