Common deficiencies with bioequivalence submissions in abbreviated new drug applications assessed by FDA

AAPS Journal

Volumn 14, Issue 1, 2012, Pages 19-22

  Liu, Qing ^a   Davit, Barbara M ^a   Cherstniakova, Svetlana A ^a   Dandamudi, Suman ^a   Walters, Johnetta F ^a   Lee, Christina H ^a   Raines, Kimberly W ^a   Ren, Ke ^a   Williamson, Leeh N ^a   Conner, Dale P ^a  

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

Author keywords

ANDA; bioequivalence; common deficiency; FDA

Indexed keywords

GENERIC DRUG;

ARTICLE; BIOEQUIVALENCE; CONTROLLED STUDY; DRUG APPROVAL; DRUG FORMULATION; DRUG INDUSTRY; DRUG MARKETING; DRUG NOMENCLATURE; DRUG PROGRAM; DRUG QUALITY; DRUG RESEARCH; DRUG SOLUBILITY; DRUG STABILITY; DRUG STORAGE; FOOD AND DRUG ADMINISTRATION; PRACTICE GUIDELINE; TOTAL QUALITY MANAGEMENT; VALIDATION PROCESS;

DOCUMENTATION; DRUG APPROVAL; DRUGS, GENERIC; HUMANS; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84857624011     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-011-9312-7     Document Type: Article

References (7)

1. Generic Pharmaceutical Association. http://www.gphaonline.org/media/ press-releases/2009/02/12/gpha-congratulates-president-elect-barack-obama-and- new-congress-and (assessed 2011, May 2)
2. Approved products with therapeutic equivalence evaluations. 31st edition. Washington, DC: US Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs, 2009. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/UCM071436.pdf (assessed 2011, May 2)
3. U.S. Food and Drug Administration Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf
4. U.S. Food and Drug Administration Guidance for Industry: Food-Effect Bioavailability and Fed Bioequivalence Studies. http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070241.pdf
5. Model Bioequivalence Data Summary Tables. http://www.fda.gov/downloads/ Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM120957.pdf
6. U.S. Food and Drug Administration External Dissolution Methods Database: http://www.accessdata.fda.gov/scripts/cder/dissolution/index.cfm
7. U.S. Food and Drug Administration Guidance for Industry: Bioequivalence Recommendations for Specific Products: http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm