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Guidance for Industry Andes: Pharmaceutical Solid Polymorphism Chemistry, Manufacturing, and Controls Information U.S. Department of Health and Human Services Food and Drug Administration Center for
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What is andas pharmaceutical solid polymorphism?
Andas pharmaceutical solid polymorphism refers to the phenomenon where a pharmaceutical substance can exist in multiple crystal forms, each with different physical properties such as melting point, solubility, and stability.
Who is required to file andas pharmaceutical solid polymorphism?
The companies or individuals seeking to obtain approval for generic drugs are required to file andas pharmaceutical solid polymorphism.
How to fill out andas pharmaceutical solid polymorphism?
Filling out andas pharmaceutical solid polymorphism involves providing detailed information on the crystal forms of the pharmaceutical substance, their characteristics, manufacturing processes, and analytical methods used for identification and quantification.
What is the purpose of andas pharmaceutical solid polymorphism?
The purpose of andas pharmaceutical solid polymorphism is to demonstrate that the generic drug's crystal form is identical or bioequivalent to the reference drug, ensuring its safety and efficacy.
What information must be reported on andas pharmaceutical solid polymorphism?
The information to be reported on andas pharmaceutical solid polymorphism includes the identification of crystal forms, their physical properties, manufacturing details, validation of analytical methods, and comparative studies with the reference drug.
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