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Volumn 62, Issue 6, 2008, Pages 429-444
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Why and how to implement a rapid sterility test
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Author keywords
Chemunex; Comparability protocol; Drug master file; Method validation; Most probable number; Rapid detection instrument; Rapid sterility test; Scan RDI; Viability method
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Indexed keywords
AGENTS ACTING ON THE EYE;
ARTICLE;
CASE STUDY;
DRUG MARKETING;
DRUG QUALITY;
DRUG STERILITY;
FEASIBILITY STUDY;
FOOD AND DRUG ADMINISTRATION;
GOOD MANUFACTURING PRACTICE;
METHODOLOGY;
MICROBIOLOGICAL EXAMINATION;
QUALITY CONTROL;
RISK ASSESSMENT;
UNITED STATES;
VALIDATION PROCESS;
DRUG CONTAMINATION;
MICROBIOLOGICAL TECHNIQUES;
STERILIZATION;
TECHNOLOGY, PHARMACEUTICAL;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
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EID: 59349115372
PISSN: 10797440
EISSN: None
Source Type: Journal
DOI: None Document Type: Article |
Times cited : (8)
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References (14)
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