Scientific considerations of pharmaceutical solid polymorphism in abbreviated new drug applications

Pharmaceutical Research

Volumn 20, Issue 4, 2003, Pages 531-536

  Yu, Lawrence X ^a   Furness, M Scott ^a   Raw, Andre ^a   Woodland Outlaw, Kathy P ^a   Nashed, Nashed E ^a   Ramos, Edwin ^a   Miller, Stephen P F ^a   Adams, Richard C ^a   Fang, Florence ^a   Patel, Rashmikant M ^a   Holcombe Jr , Frank O ^a   Chiu, Yuan Yuan ^a   Hussain, Ajaz S ^a  

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

Author keywords

Abbreviated New Drug Application (ANDA); Drug product; Drug substance; Pharmaceutical solid; Polymorph; Polymorphism

Indexed keywords

GENERIC DRUG;

CRYSTALLIZATION; DRUG BIOAVAILABILITY; DRUG FORMULATION; DRUG MANUFACTURE; DRUG SOLUBILITY; DRUG STRUCTURE; INFRARED SPECTROSCOPY; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; PHYSICAL CHEMISTRY; PRIORITY JOURNAL; RAMAN SPECTROMETRY; REVIEW; SOLID STATE; STOICHIOMETRY; THERMODYNAMICS; X RAY DIFFRACTION;

CHEMISTRY, PHARMACEUTICAL; DECISION TREES; DRUG APPROVAL; TECHNOLOGY, PHARMACEUTICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 12444319935     PISSN: 07248741     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1023285627778     Document Type: Review

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