Common deficiencies in abbreviated new drug applications: part 1: Drug substance

Pharmaceutical Technology

Volumn 34, Issue 1, 2010, Pages 50-59

  Srinivasan, Aloka ^a   Iser, Robert ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

DRUG SUBSTANCES; GENERIC DRUGS; IN-BUILDINGS; NEW DRUG APPLICATIONS; TEAM LEADERS; US FOOD AND DRUG ADMINISTRATION;

GENERIC DRUG; NEW DRUG;

CHIRALITY; DRUG IDENTIFICATION; DRUG IMPURITY; DRUG INFORMATION; DRUG MANUFACTURE; DRUG QUALITY; DRUG STABILITY; REVIEW;

EID: 77952160139     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (16)

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13. ICH, Q6A, Federal Register: 65(251) (Dec. 29, 2000).
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15. S. Zhigang et al., Amer. Pharma. Rev., in press.
16. FDA, "21 CFR 211 Current Good Manufacturing Practices for Finished Pharmaceuticals, Subpart J," [Records and Reports, Sec. 211.194 (a)(2)].