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Volumn 17, Issue 1, 2011, Pages 139-147

Criteria for safety evaluation of antimicrobial agents

(17)  Watanabe, Akira a,o   Tokue, Yutaka b   Aoki, Nobuki c   Matsumoto, Tetsuro d   Yanagihara, Katsunori e   Higa, Futoshi f   Tsuge, Hiroyuki g   Nagashima, Masahito h   Matsuoka, Hiromi g   Sasagawa, Yuji i   Matsumoto, Masato i   Fujimaki, Kazuo j   Taguchi, Kenji j   Ariyasu, Mari k   Yamamoto, Norifumi l   Kunii, Otohiko m   Shiba, Kohya n  


Author keywords

Antimicrobial agent; Clinical trial; Safety evaluation criteria

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ANTIINFECTIVE AGENT; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CHLORIDE; CREATINE KINASE; CREATININE; CYTOSOL AMINOPEPTIDASE; GAMMA GLUTAMYLTRANSFERASE; GLUCOSE; HEMOGLOBIN; LACTATE DEHYDROGENASE; POTASSIUM; SODIUM;

EID: 79951553517     PISSN: 1341321X     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10156-010-0183-0     Document Type: Article
Times cited : (18)

References (6)
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    • Japanese Society of Chemotherapy 1991 Criteria for assessment of adverse reactions and abnormal laboratory values associated with antimicrobial agents in study subjects Jpn J Chemother 39 687 689
    • (1991) Jpn J Chemother , vol.39 , pp. 687-689
  • 2
    • 79951556535 scopus 로고
    • About the partial modification of "criteria for assessment of adverse reactions and abnormal laboratory values associated with antimicrobial agents in study subjects"
    • Japanese Society of Chemotherapy the opening article
    • Japanese Society of Chemotherapy. About the partial modification of "Criteria for assessment of adverse reactions and abnormal laboratory values associated with antimicrobial agents in study subjects". Jpn J Chemother. 1995; 43 (the opening article).
    • (1995) Jpn J Chemother , vol.43
  • 3
    • 33751224005 scopus 로고    scopus 로고
    • Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for Japanese
    • JCOG/JSCO
    • JCOG/JSCO 2004 Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for Japanese Int J Clin Oncol 9 Supp III 1 82
    • (2004) Int J Clin Oncol , vol.9 , Issue.SUPPL. III , pp. 1-82
  • 4
    • 79951555700 scopus 로고    scopus 로고
    • Committee interim report: Criteria for assessment of abnormal laboratory values associated with antimicrobial agents (draft v.0.2)
    • Japanese Society of Chemotherapy
    • Japanese Society of Chemotherapy 2009 Committee interim report: criteria for assessment of abnormal laboratory values associated with antimicrobial agents (draft v.0.2) Jpn J Chemother 57 320 342
    • (2009) Jpn J Chemother , vol.57 , pp. 320-342
  • 5
    • 85030591685 scopus 로고    scopus 로고
    • The international conference on harmonization of technical requirements for registration of pharmaceuticals for human Use (ICH). Clinical safety data management: definitions and standards for expedited reporting. ICH harmonized tripartite guideline. Recommended for Adoption at Step 4 of the ICH Process on 27 October 1994
    • The international conference on harmonization of technical requirements for registration of pharmaceuticals for human Use (ICH). Clinical safety data management: definitions and standards for expedited reporting. ICH harmonized tripartite guideline. Recommended for Adoption at Step 4 of the ICH Process on 27 October 1994.
  • 6
    • 79951555000 scopus 로고    scopus 로고
    • Criteria for assessment of antimicrobial agents in pediatric clinical study
    • Japanese Society of Chemotherapy
    • Japanese Society of Chemotherapy. Criteria for assessment of antimicrobial agents in pediatric clinical study. Jpn J Chemother 2003; 51:144-51.
    • (2003) Jpn J Chemother , vol.51 , pp. 144-151


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.