Document Detail

Pharmaceutical solids: a strategic approach to regulatory considerations.
MedLine Citation:
PMID:  7494814     Owner:  NLM     Status:  MEDLINE    
PURPOSE: This review describes a conceptual approach to the characterization of pharmaceutical solids. METHODS: Four flow charts are presented: (1) polymorphs, (2) hydrates, (3) desolvated solvates, and (4) amorphous forms. RESULTS: These flow charts (decision trees) are suggested as tools to develop information on pharmaceutical solids for both scientific and regulatory purposes. CONCLUSIONS: It is hoped that this review will lead to a more direct approach to the characterization of pharmaceutical solids and ultimately to faster approval of regulatory documents containing information on pharmaceutical solids.
S Byrn; R Pfeiffer; M Ganey; C Hoiberg; G Poochikian
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Review    
Journal Detail:
Title:  Pharmaceutical research     Volume:  12     ISSN:  0724-8741     ISO Abbreviation:  Pharm. Res.     Publication Date:  1995 Jul 
Date Detail:
Created Date:  1996-01-11     Completed Date:  1996-01-11     Revised Date:  2010-03-24    
Medline Journal Info:
Nlm Unique ID:  8406521     Medline TA:  Pharm Res     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  945-54     Citation Subset:  IM    
Department of Medicinal Chemistry and Pharmacognosy, Purdue University, West Lafayette, Indiana 47907, USA.
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MeSH Terms
Chemistry, Pharmaceutical / methods*
Chemistry, Physical
Decision Trees
Drug and Narcotic Control*
Pharmaceutical Preparations / chemistry*
Physicochemical Phenomena
Reg. No./Substance:
0/Pharmaceutical Preparations

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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