SCOPUS 정보 검색 플랫폼

Volumn 18, Issue 12, 2001, Pages 1645-1650

Bioavailability and bioequivalence: An FDA regulatory overview

(14) Chen, M L a Shah, V a Patnaik, R a Adams, W a Hussain, A a Conner, D a Mehta, M a Malinowski, H a Lazor, J a Huang, S M a Hare, D a Lesko, L a Sporn, D a,b Williams, R a,c

a CENTER FOR DRUG EVALUATION AND RESEARCH (United States)

b ABBOTT LABORATORIES (United States)

c UNITED STATES PHARMACOPEIA (United States)

Author keywords

Abbreviated New Drug Applications; Bioavailability; Bioequivalence; Generic drugs; Guidances; New Drug Applications

Indexed keywords

GENERIC DRUG; NEW DRUG;

BIOEQUIVALENCE; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG DEVELOPMENT; DRUG HALF LIFE; DRUG MANUFACTURE; DRUG SOLUBILITY; ENANTIOMER; FOOD AND DRUG ADMINISTRATION; PHARMACODYNAMICS; PRIORITY JOURNAL; RACEMIC MIXTURE; REVIEW; STEADY STATE;

BIOLOGICAL AVAILABILITY; DRUG APPROVAL; DRUGS, GENERIC; DRUGS, INVESTIGATIONAL; LEGISLATION, DRUG; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0035659563 PISSN: 07248741 EISSN: None Source Type: Journal
DOI: 10.1023/A:1013319408893 Document Type: Review

Times cited : (189)

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