Regulatory considerations for developing drugs for rare diseases: orphan designations and early phase clinical trials.

Discovery medicine

Volumn 11, Issue 59, 2011, Pages 367-375

  Pariser, Anne R ^a   Xu, Kui ^b   Milto, John ^b   Coté, Timothy R ^b  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ANIMAL; CLINICAL TRIAL (TOPIC); DRUG DEVELOPMENT; DRUG LEGISLATION; DRUG MANUFACTURE; HUMAN; LEGAL ASPECT; RARE DISEASE; REVIEW;

ANIMALS; CLINICAL TRIALS AS TOPIC; DRUG DISCOVERY; HUMANS; LEGISLATION, DRUG; ORPHAN DRUG PRODUCTION; RARE DISEASES;

EID: 80053337529     PISSN: None     EISSN: 19447930     Source Type: Journal    
DOI: None     Document Type: Review

References (0)