SCOPUS 정보 검색 플랫폼

Volumn 19, Issue 3, 2002, Pages 217-226

Chemistry, manufacturing, and controls information in NDAs and ANDAs, supplements, annual reports, and other regulatory filings

(2) Sheinin, Eric a Williams, Roger a

a UNITED STATES PHARMACOPEIA (United States)

Author keywords

21 CFR 312; 21 CFR 314, CDER CMC guidances; ANDAs; Annual reports; Bioavailability; Bioequivalence; CDER Microbiology guidances; Federal Food, Drug and Cosmetic Act; INDs; NDAs; NF; Supplements; USP

Indexed keywords

NEW DRUG;

DIET SUPPLEMENTATION; DRUG APPROVAL; DRUG INDUSTRY; DRUG MANUFACTURE; FOOD AND DRUG ADMINISTRATION; LAW; PRIORITY JOURNAL; REVIEW;

ANNUAL REPORTS; DRUG APPROVAL; HUMANS; PRACTICE GUIDELINES; TECHNOLOGY, PHARMACEUTICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0036197498 PISSN: 07248741 EISSN: None Source Type: Journal
DOI: 10.1023/A:1014437513188 Document Type: Review

Times cited : (7)

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