Scientific Considerations of Pharmaceutical Solid Polymorphism in Regulatory Applications

Polymorphism: in the Pharmaceutical Industry

Volumn , Issue , 2006, Pages 385-403

  Miller, Stephen P F ^a   Raw, Andre S ^a   Yu, Lawrence X ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

General principles of pharmaceutical solid polymorphs; Influence of polymorphism on product performance; Influence of polymorphism on product quality; Pharmaceutical industry; Pharmaceutical solid polymorphism in drug product; Pharmaceutical solid polymorphism in drug substance; Polymorphism; Process analytical technology; Regulatory applications; Scientific considerations

Indexed keywords

EID: 52149105020     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/3527607889.ch15     Document Type: Chapter

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