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Regulatory considerations for a standard clinical development plan for registration in the us and eu and the nonclinical studies required at each stage
Author(s) -
Curley R.,
Bigora S.E.
Publication year - 2003
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/s0009-9236(03)90370-5
Subject(s) - drug approval , product (mathematics) , medicine , business , pharmacology , computer science , mathematics , drug , geometry
Clinical Pharmacology & Therapeutics (2003) 73 , P4–P4; doi: