Questions and Answers
Which act added proof of efficacy requirement components to the regulatory review process in the United States?
The Kefauver-Harris Amendment of 1962
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
What does polymorphism refer to in the context of drug development?
The ability of a solid material to exist in more than one crystalline form
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?
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