Term
| What physiochemical details does the FDA require for an IND application |
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Definition
Structure
Molecular Weight
Melting Point
pKa
logP
logD7.4
Salt selection
Demonstrate drug stability |
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Term
| What tests are used to demonstrate the stability of a drug? |
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Definition
Florida Test
X-Ray Powder Diffraction |
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Term
| What are the parameters of the Florida Test? |
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Definition
| 45 Degrees Celsius with a cup of water in an oven for multiple days |
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Term
| What is the purpose of X-Ray Powder Diffraction? |
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Definition
Identify different polymorphs
Confirm stability of drugs after exposure to heat, light, etc. |
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Term
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Definition
| Solid materials that exist in more than one form |
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Term
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Definition
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Term
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Definition
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Term
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Definition
| Good Manufacturing Process |
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Term
| What does a GMP facility do? |
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Definition
| Manufacture drug and provide painstaking detail about the process for the IND application |
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Term
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Definition
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Term
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Definition
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Term
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Definition
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Term
| What values can different salts affect? |
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Definition
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Term
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Definition
| Chemical Manufacturing and Control |
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Term
| What details about drug components do CMCs provide in their documentation? |
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Definition
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Term
| What is the FDA requirement for drug purity? |
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Definition
| Every impurity that exists above .05% or more than 1mg/day must be accounted for and tested for safety |
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Term
| What is the purpose of the Ames Test? |
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Definition
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Term
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Definition
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Term
| What trial phase uses randomized discontinuation trials? |
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Definition
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Term
| To be considered an orphan disease, what is the maximum number of patients in the US? |
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Definition
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