Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan

Clinical Pharmacology and Therapeutics

Volumn 78, Issue 2, 2005, Pages 102-113

  Uyama, Yoshiaki ^a   Shibata, Taro ^b   Nagai, Naomi ^b   Hanaoka, Hideki ^b   Toyoshima, Satoshi ^b   Mori, Kazuhiko ^b  

^a PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ALENDRONIC ACID; AMOXICILLIN; ANASTROZOLE; BASILIXIMAB; BENZOPORPHYRIN DERIVATIVE; BRINZOLAMIDE; CLARITHROMYCIN; DONEPEZIL; ELETRIPTAN; EXEMESTANE; FEXOFENADINE; FOLINATE CALCIUM; GEFITINIB; GOSERELIN; INFLIXIMAB; INSULIN ASPART; LEFLUNOMIDE; METHOTREXATE; OMEPRAZOLE; OSELTAMIVIR; PALIVIZUMAB; PRAMIPEXOLE; RISEDRONIC ACID; RIZATRIPTAN; SILDENAFIL; SUMATRIPTAN SUCCINATE; TIMOLOL; UFT; ZOLMITRIPTAN;

AREA UNDER THE CURVE; DOSE CALCULATION; DOSE RESPONSE; DRUG ABSORPTION; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG INDICATION; DRUG INFORMATION; DRUG SAFETY; DRUG SCREENING; DRUG USE; ETHNIC DIFFERENCE; HEALTH CARE ORGANIZATION; HUMAN; INFORMATION PROCESSING; JAPAN; NAUSEA; NOTE; PRACTICE GUIDELINE; PRESCRIPTION; PRIORITY JOURNAL; RESEARCH ETHICS; SOMNOLENCE; VISUAL IMPAIRMENT;

CLINICAL TRIALS; DRUG APPROVAL; GUIDELINES; HUMANS; INVESTIGATIONAL NEW DRUG APPLICATION; JAPAN;

EID: 23444432195     PISSN: 00099236     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.clpt.2005.04.001     Document Type: Note

References (13)

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