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Volumn 5, Issue 2, 1999, Pages 110-123

Clinical evaluation methods for new antimicrobial agents to treat respiratory infections: Report of the Committee for the Respiratory System, Japan Society of Chemotherapy

Author keywords

Antimicrobial agents; Clinical evaluation method; Committee report; Respiratory infection

Indexed keywords

ANTIINFECTIVE AGENT; C REACTIVE PROTEIN; NEW DRUG;

EID: 0032982548     PISSN: 1341321X     EISSN: None     Source Type: Journal    
DOI: 10.1007/s101560050020     Document Type: Article
Times cited : (42)

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