Document Detail

Pharmaceutical impurities: regulatory perspective for Abbreviated New Drug Applications.
MedLine Citation:
PMID:  17196703     Owner:  NLM     Status:  MEDLINE    
Impurities in drug substances and drug products have been important regulatory issues in the Office of Generic Drugs by having significant impact on the approvability of Abbreviated New Drug Application (ANDAs). This review begins with a discussion of ANDAs and its similarity/differences with NDAs, highlighting the importance of control of pharmaceutical impurities in generic drug product development and regulatory assessment. An overview of the FDA draft guidance documents "ANDAs: Impurities in Drug Substances" and "ANDAs: Impurities in Drug Products" are provided. This introduces the identification and qualification procedures for ANDAs and approaches to the establishment of acceptance criteria for both drug substance and drug product. Case studies included in this review illustrate the proposed pathway for determination of impurities and their acceptance criteria, based upon the general principles of these guidances.
Arup K Basak; Andre S Raw; Ali H Al Hakim; Scott Furness; Nashed I Samaan; Devinder S Gill; Hasmukh B Patel; Roslyn F Powers; Lawrence Yu
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Publication Detail:
Type:  Journal Article; Review     Date:  2006-11-15
Journal Detail:
Title:  Advanced drug delivery reviews     Volume:  59     ISSN:  0169-409X     ISO Abbreviation:  Adv. Drug Deliv. Rev.     Publication Date:  2007 Jan 
Date Detail:
Created Date:  2007-02-12     Completed Date:  2007-04-05     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8710523     Medline TA:  Adv Drug Deliv Rev     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  64-72     Citation Subset:  IM    
Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, USA.
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MeSH Terms
Drug Approval*
Drug Contamination / legislation & jurisprudence*,  prevention & control
Drugs, Generic* / analysis
United States
United States Food and Drug Administration
Reg. No./Substance:
0/Drugs, Generic

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