Significant differences in drug lag in clinical development among various strategies used for regulatory submissions in Japan

Clinical Pharmacology and Therapeutics

Volumn 95, Issue 5, 2014, Pages 533-541

  Ueno, T ^a,b   Asahina, Y ^a   Tanaka, A ^a   Yamada, H ^a,b   Nakamura, M ^b   Uyama, Y ^a,c  

^a PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

^b GIFU PHARMACEUTICAL UNIVERSITY   (Japan)

^c CHIBA UNIVERSITY   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; IMMUNOMODULATING AGENT; NEW DRUG;

ARTICLE; CLINICAL TRIAL (TOPIC); DRUG APPROVAL; DRUG DEVELOPMENT; DRUG LEGISLATION; DRUG MARKETING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HUMAN; JAPAN; PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; SAMPLE SIZE; WORLD HEALTH ORGANIZATION;

CLINICAL TRIALS AS TOPIC; DRUG AND NARCOTIC CONTROL; DRUG APPROVAL; DRUG DESIGN; HUMANS; JAPAN; SAMPLE SIZE; TIME FACTORS; UNITED STATES;

EID: 84898972369     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2013.223     Document Type: Article

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