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From course:

DRUG DISCOVERY DEVELOPMENT (DDD)

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Question:

In this Step, you must show how the drug is: 1 Manufactured 2 Appears (color, solubility, melting point, particle size, moisture content) 3 Formulated (Pills, liquid, etc + inactive ingredients) 4 Will be analyzed for purity, concentration, stability 5 Will be tested for safety (BASIS for human testing)

Author: LEIGHTON DWIGHT OBILLOS



Answer:

Application is made to the Food & Drug Administration as an Investigational New Drug (IND) STEP 5


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