Drug Discovery and Development Regulations Quiz
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Questions and Answers

Which act added proof of efficacy requirement components to the regulatory review process in the United States?

  • The Food and Drug, and Cosmetic Act of 1938
  • The Food and Drug Administration (FDA) Act of 2009
  • The Kefauver-Harris Amendment of 1962 (correct)
  • The Philippine National Health Research System Act of 2013
  • What must be established to initiate a clinical program?

  • Production methods capable of generating pharmaceutical grade active pharmaceutical ingredient (API) under good manufacturing practice (GMP) conditions (correct)
  • The ability of a solid material to exist in more than one crystalline form
  • Proof of efficacy requirement components
  • Changes in synthetic pathways
  • What does polymorphism refer to in the context of drug development?

  • Drug delivery to patients given as per orem (PO)
  • Changes in synthetic pathways
  • Proof of efficacy requirement components
  • The ability of a solid material to exist in more than one crystalline form (correct)
  • What method is approximately used for 70% of the marketed medications delivered to patients?

    <p>Per orem (PO)</p> Signup and view all the answers

    Which administrative order streamlined the regulation and guidelines in the conduct of clinical trials for investigational products in the Philippines?

    <p>Administrative Order 2020-0010</p> Signup and view all the answers

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