The FDA's generic-drug approval process: Similarities to and differences from brand-name drugs

American Journal of Gastroenterology

Volumn 106, Issue 6, 2011, Pages 1018-1021

  Kefalas, Costas H ^a,b   Ciociola, Arthur A ^c  

^a Northeast Ohio Medical University   (United States)

^b Akron Digestive Disease Consultants Inc   (United States)

^c Process and Policy Bausch+Lomb   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ATROPINE; ATROPINE PLUS DIPHENOXYLATE; AZATHIOPRINE; BALSALAZIDE; BICARBONATE PLUS MACROGOL 3350 PLUS POTASSIUM CHLORIDE PLUS SODIUM CHLORIDE; CALCIUM ACETATE; CIMETIDINE; COLESTYRAMINE; CYCLOSPORIN A; DICYCLOVERINE; DRONABINOL; FAMOTIDINE; GENERIC DRUG; GLYCOPYRRONIUM BROMIDE; GRANISETRON; HYOSCYAMINE; LACTULOSE; LANSOPRAZOLE; LOPERAMIDE; MECLOZINE; MESALAZINE; METHYLPREDNISOLONE; METOCLOPRAMIDE; MISOPROSTOL; NIZATIDINE; OCTREOTIDE; OMEPRAZOLE; ONDANSETRON; PANTOPRAZOLE; PROCHLORPERAZINE MALEATE; PROMETHAZINE; RANITIDINE; SALAZOSULFAPYRIDINE; SUCRALFATE; UNINDEXED DRUG; URSODEOXYCHOLIC ACID;

ARTICLE; BIOEQUIVALENCE; DRUG APPROVAL; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; HUMAN; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; QUALITY CONTROL;

CLINICAL TRIALS, PHASE I AS TOPIC; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; DRUG APPROVAL; DRUG LABELING; DRUGS, GENERIC; FEMALE; HUMANS; MALE; PHARMACEUTICAL PREPARATIONS; SENSITIVITY AND SPECIFICITY; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79957975327     PISSN: 00029270     EISSN: 15720241     Source Type: Journal    
DOI: 10.1038/ajg.2011.29     Document Type: Article

References (9)

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8. US Food and Drug Administration. Center for Drug Evaluation and Research, Division of Drug Information. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations. BP, Revision 1 http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/default.htm (March 2003).
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