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Questions and Answers
Which act added proof of efficacy requirement components to the regulatory review process in the United States?
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?
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?
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?
What method is approximately used for 70% of the marketed medications delivered to patients?
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Which administrative order streamlined the regulation and guidelines in the conduct of clinical trials for investigational products in the Philippines?
Which administrative order streamlined the regulation and guidelines in the conduct of clinical trials for investigational products in the Philippines?
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